Restricted Eating Time in the Treatment of Type 2 Diabetes

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Keywords

• Time-restricted eating
• Type 2 Diabetes
• Obesity
• Overweight
• Fasting
• Circadian rhythm

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 160 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  Time-restricted eating

  TRE group for 1 year: The intervention consists of a 3-month (12 weeks) strict TRE period, where participants follow the same eating window each day with minimal support, followed by a 9-month (40 weeks) period of individually adjusted TRE according to their experiences.

  Other: Time restricted eating

• No intervention
  Control

  Control group for 1 year: Participants will be instructed to continue their habitual lifestyle during the study and they will follow standard care with regular visits at the SDCC clinic 3-4 times/year.

Interventions

• OtherTime restricted eating

  3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions. 9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.

Primary outcomes

1. Change in HbA1c (mmol/mol)

   Assessed from blood samples in fasted state.

   Time frame: Change from baseline to 3-months of intervention (strict TRE)

2. Change in HbA1c (mmol/mol)

   Assessed from blood samples in fasted state.

   Time frame: Change from baseline to the end of the intervention (12 months)

Secondary outcomes

1. Body weight (kg)

   Measured on a digital scale in a fasted state.

   Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

2. Fat mass (kg)

   Measured by Dual-energy X-ray Absorptiometry in a fasted state.

   Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

3. Time in range (% 3.9-10.0 mmol/l)

   Measured using continous glucose monitoring.

   Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

4. Use of antidiabetic medication

   Change in current use of antidiabetic medication from baseline to end of the intervention (12 months).

   Time frame: Change from baseline to end of the intervention (12 months). Assessed at baseline, 3 months, 12 months.

Other outcomes

1. Body weight (kg)

   Measured on a digital scale in a fasted state.

   Time frame: Change from baseline to 3 months

2. Height (m)

   Height will be measured in order to calculate BMI.

   Time frame: Measured only at screening

3. Body mass index (kg/m^2)

   Weight and height measurements will be used to calculate BMI in kg/m\^2.

   Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

4. Fat mass (kg)

   Measured by Dual-energy X-ray Absorptiometry in a fasted state.

   Time frame: Change from baseline to 3 months

5. Time in range (% 3.9-10.0 mmol/l)

   Measured using continous glucose monitoring.

   Time frame: Change from baseline to 3 months

6. Use of antidiabetic medication

   Change in current use of antidiabetic medication from baseline to 3 months

   Time frame: Change from baseline to 3 months

7. Change in overall medication use

   Change in medication use (e.g. blood pressure, lipid-lowering medication etc)

   Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

8. Blood lipids (mmol/l)

   Fasting concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides

   Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

9. Fat free mass (kg)

   Measured by Dual-energy X-ray Absorptiometry in a fasted state.

   Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

10. Hormones-Insulin (pmol/L)

    Fasting concentration of insulin

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

11. Hormones-Glucagon (pmol/L)

    Fasting concentration of glucagon

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

12. Hormones-C-peptide (pmol/L)

    Fasting concentration of C-peptide

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

13. Hormones-Leptin (pmol/L)

    Fasting concentration of leptin

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

14. Hormones-Fibroblast growth factor 21 (pmol/L)

    Fasting concentration of fibroblast growth factor 21

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

15. Hormones-Glucagon-like peptide-1 (pmol/L)

    Fasting concentration of glucagon-like peptide-1

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

16. Hormones-Glucose-dependent insulinotropic polypeptide (pmol/L)

    Fasting concentration of glucose-dependent insulinotropic polypeptide

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

17. Hormones-Ghrelin (pmol/L)

    Fasting concentration of ghrelin

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

18. Hormones-Peptide YY (pmol/L)

    Fasting concentration of peptide YY

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

19. Hormones-Neuropeptide Y (pmol/L)

    Fasting concentration of neuropeptide Y

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

20. Hormones-Growth differentiating factor 15 (pmol/L)

    Fasting concentration of growth differentiating factor 15

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

21. Marker of kidney function - Creatinine (µmol/L)

    Fasting concentration of creatinine

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

22. Marker of kidney function - eGFR (mL/min)

    Estimated glomerular filtration rate (eGFR)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

23. Plasma beta-hydroxybutyrate (mmol/L)

    Fasting concentration of plasma beta-hydroxybutyrate

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

24. Marker of liver function - Aspartate-aminotransferase (U/L)

    Fasting concentration of aspartate-aminotransferase

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

25. Marker of liver function - Alanine aminotransferase (U/L)

    Fasting concentration of alanine-aminotransferase

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

26. Marker of liver function - Thrombocytes (x10^9/L)

    Fasting concentration of thrombocytes (for estimating liver-fibrosis)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

27. Markers of inflammation- Tumor necrosis factor alpha (pmol/L)

    Fasting concentration of Tumor necrosis factor alpha

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

28. Markers of inflammation-Adiponectin (pmol/L)

    Fasting concentration of adiponectin

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

29. Markers of inflammation-C-reactive protein (mg/L)

    Fasting concentration of C-reactive protein

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

30. Markers of inflammation-Interleukin 6 (pmol/L)

    Fasting concentration of interleukin 6

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

31. Time Below Range (% <3.9 mmol/l)

    Measured using continous glucose monitoring.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

32. Time Above Range (% >10.0 mmol/l)

    Measured using continous glucose monitoring.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

33. Coefficient of variation (CV) of glucose concentrations

    Measured using continous glucose monitoring.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

34. Mean glucose concentrations

    Measured using continous glucose monitoring.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

35. Standard deviation of glucose concentrations

    Measured using continous glucose monitoring.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

36. Systolic blood pressure (mmHg)

    Measured in a fasted and rest state.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

37. Diastolic blood pressure (mmHg)

    Measured in a fasted and rest state.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

38. Resting heart rate (bpm)

    Measured in a fasted and rest state.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

39. Waist circumference (cm)

    Measured using tape measure in a fasted state. The average of three consecutive measurements is reported.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

40. Hip circumference (cm)

    Measured using tape measure in a fasted state.The average of three consecutive measurements is reported.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

41. Waist/hip ratio

    The ratio of the circumference of the waist to that of the hips.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

42. Degree of liver fibrosis (kPa)

    Measured by FibroScan in a fasted state.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

43. Degree of liver steatosis (dB/m)

    Measured by FibroScan in a fasted state.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

44. Food choice

    Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

45. Attention

    Measured using eye tracking in response to looking at food pictures during the SBFPT. Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score \>0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score \<0.5 indicates attention towards the other food images.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

46. Reaction time (ms)

    Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

47. Explicit liking

    Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales (VAS) and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

48. Explicit wanting

    Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using VAS and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

49. Implicit wanting

    Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm). In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred.The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value).

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

50. Self-reported binge eating disorder

    Assessed from 2 questions (question 13,14) of Binge Eating Disorder Examination Questionnaire (EDE-Q 6.0).

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

51. Self-reported physical activity

    Assessed from the Physical Activity Scale 1 (PAS1)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

52. Self-reported sleep quality

    Assessed from the Pittsburgh Sleep Quality Index (PSQI).The questionnaire consists of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

53. Self-reported information on social relations and social support

    Assessed from 2 items (items 68 and 70) of social relations and social support questionnaire (the Danish National Health Survey, item 68 and 70). The questions refer to contact with other people.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

54. Self-reported sleepiness

    Assessed from the Epworth Sleepiness Scale (ESS).The questionnaire consists of 8 questions, which is weighted on a 0-3 interval scale. A low total score can be interpreted as a normal daytime sleepiness, and a higher score as a mild, moderate and severe excessive daytime sleepiness, respectively.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

55. Self-reported eating behavior

    Assessed from the Dutch Eating Behavior Questionnaire (DEBQ). The questionnaire consists of 33 items and comprises three scales that measure emotional, external and restrained eating.Items can be rated from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

56. Self-reported night eating

    Assessed from the Night Eating Questionnaire (NEQ). The questionnaire consists of 14 items, that can be rated from 0 to 4. All items except item 13 are summed to obtain a global score. A total score ≥ 25 has been proposed as a lenient threshold for night eating syndrome.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

57. Self-reported food intake

    Assessed from the food intake questionnaire (23-item FFQ). The questionnaire collects dietary data and uses a context-specific food list to estimate the usual diet.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

58. Self-reported diabetes distress

    Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥ 8 indicates possible diabetes related emotional distress.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

59. Self-reported sexual functioning/well-being

    Assessed from 1 item of the questionnaire the Danish National Health Survey (item 79) and 4 items of the questionnaire Danish PRO scheme (diabetes) (item 46 and 63-65).

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

60. Self-reported mood

    Assessed from the Major Depression Inventory (MDI). The questionnaire consists of 10 items. Each item can be rated from 0 to 5.The total score ranges from 0 to 50. A total score \<20 indicates depression does not exist or its existence is doubtful, 20-24 indicates mild depression, 25-29 indicates moderate depression, and \>29 indicates severe depression.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

61. Self-assessed questionnaire to determine morningness-eveningness in human circadian rhythm

    Assessed by the Morningness-Eveningness Questionnaire (MEQ). The questionnaire consists of 19 items. Each item can be rated from 0 to 4-7. The total score ranges from 16 to 86. The lower score the more eveningness, and the higher score the more morningness.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

62. Subjective appetite

    Subjective appetite will be assessed using Visual analogue scales (VAS), including ratings of hunger, fullness, satiety and prospective food consumption, thirst, desire to eat something sweet, salty, fatty, meat, and potential nausea.

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

63. Cognition

    Cognitive functions will be assessed by Screen for Cognitive Impairment in Psychiatry Danish Version (SCIP-D) together with the Trail Making Test-Part B (psychomotor speed and executive function) and the Cognitive Failures Questionnaire

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

64. Dim light melatonin onset (DLMO) (subgroup only)

    DLMO is a standard biomarker for measuring circadian rhythms and can easily be measured at home by saliva sampling. Saliva samples must be taken every 60 minutes under dim light (\<30 lux) for at least 1 hour prior to and throughout the expected rise in melatonin.

    Time frame: Change from baseline to 3 months. Measured at baseline and 3 months

65. Brain insulin resistance (subgroup only)

    Cerebral blood flow assessed by MRI in response to intranasal insulin administration in a subgroup of participants. A basal MRI will be conducted and afterwards 160 U insulin will be administered intranasally by spraying 2 puffs per nostril (each containing 10 U of insulin) every minute over 4 minutes followed by MRI 30 minutes after the last administration

    Time frame: Change from baseline to 3 months. Assessed at baseline and 3 months.

66. Adherence (%)

    Degree of adherence to eating windows = (number of days where eating window was reduced by minimum 3 hours compared to habitual eating window and participants have reported an eating window below 10 hours / total number of days in intervention) \* 100%.

    Time frame: Registered 2 days/week on random days via an online questionnaire.

67. Degree of participants' participation in intervention activities - Visits

    Assessed from % participation in the 5 intervention visits

    Time frame: Visit 1, visit 2, visit 3, visit 4, visit 5

68. Degree of participants' participation in intervention activities - Conversations

    Assessed from % participation in the conversations at visit 1 and 3 (TRE group only)

    Time frame: Conversations at visit 1 and visit 3

69. Degree of participants' participation in intervention activities - Peer support group meetings

    Assessed from % participation in peer support group meetings (TRE group only)

    Time frame: Support group meetings will be held once monthly

70. Degree of participants' participation in intervention activities - Phone calls

    Assessed from % participation in the phone calls (TRE group only)

    Time frame: Phone calls after 2, 6, 9 weeks + Phone calls after 6 and 9 months

71. Participants' acceptance of TRE

    Assessed by interviews on participants' acceptance of TRE in terms of bodily/physical experiences, motivation, and ability to manage TRE in daily living and how intervention activities were supportive. This refers only to the TRE group. Individual interviews will be conducted by a qualitative researcher with a sub-group of participants in the TRE group (n=30) representing experiences with a variety of individual adjustments after the last visit, and focus group interviews will be performed with a sub-group of participants in the TRE group (n=30) choosing peer support or family involvement. Participants are free to say yes or no to participate in interviews.These interviews will be audio recorded.

    Time frame: The interviews will be conducted at the end of intervention (1 year after baseline) at visit 5

72. Energy intake (kJ)

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

73. Fat energy percent

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

74. Carbohydrate energy percent

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

75. Protein energy percent

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

76. Alcohol energy percent

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

77. Dietary fibers (gram)

    Assessed from 3-day dietary records

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

Individual participant data

Plan to share: No