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CompletedNCT02417012Updated Dec 13, 2018

Lifestyle and Glucose Lowering Medication in T2DM

An interventional study of U-TURN and Standard care in Diabetes Mellitus, Type 2, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the effect of a lifestyle intervention maintenance of glycemic control while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The intervention group receives an intensive lifestyle intervention including exercise and diet lifestyle modifications. The reference group receives diabetes educational advice. Both groups will have their pharmacological treatment regulated across the study. The primary hypothesis is that lifestyle change is sufficient to maintain glycemic control while decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.

Read the detailed description

Adherence to lifestyle modifications including increased exercise and healthy diet improves glycemic control in patients with type 2 diabetes mellitus. However, few have investigated the combined effects of these lifestyle changes on maintenance of glycemic control while decreasing the usage of anti-diabetic medications.

The primary hypothesis is that lifestyle change is equivalent in maintaining glycemic control (Hba1c) compared to the standard pharmacological treatment,

The U-TURN trial also tests the effects on one key secondary outcome (glucose lowering medication) and examines the effects on sleep quality, fatigue sleepiness, sleep pattern, cardio vascular disease risk factors, psychological outcomes, blood pressure and cholesterol lowering medication. The participants (N=120) is randomized into a experimental group (N=80) and a standard care group (N=40).

Additionally, the effects of the study will be evaluated 24 month post randomization.

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Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • lifestyle
  • exercise
  • physical activity
  • diet
  • glycemic control
  • hba1c
  • glucose lowering drugs
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 97 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Less than three anti-diabetic medications.
  • Diabetes 2 duration of max 10 years
  • BMI >25 but \<40 kg/m2,
  • Accept of medical regulation by the UTURN endocrinologists only
  • Accept of purchasing a fitness club membership through U-TURN collaborator

Exclusion criteria

Exclusion Criteria:

  • Hba1c> 9% (75 mmol/mol)
  • Insulin usage
  • Presence of one or more of the following micro- and macrovascular complications of T2DM; a.Diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. Macro-albuminuria or nephropathy c. Diabetic neuropathy (except mild affected vibratory testing (\<50 Volt)) d. Arterial insufficiency e. Ischemic heart disease
  • Steroid treatment (inhalation) until three months before the medical examination
  • TSH raised/below the normal range
  • Liver disease (ALAT/ASAT thrice normal range)
  • Inability or contraindication to increased levels of physical activity (Pedersen BK and Saltin B)
  • Evidence of anaemia
  • Lung disease (except mild asthma and mild chronic obstructive pulmonary disease)
  • Heart disease
  • Kidney disease (creatinine above 130 µM or macro albuminuria)
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
97 participants (estimated)

Study arms

  • Experimental
    U-TURN intervention

    The intervention group will receive an intensive lifestyle intervention including partly supervised aerobic and strength exercise, diet plans and counseling by clinical dietitians. All exercise will be supervised initially and the supervision will be reduced gradually across the 12-month intervention. Additionally, the participants will be offered educational classes on implementation of a healthy lifestyle and diabetes education and support by trained nurses. Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.

    Behavioral: U-TURN

  • Active comparator
    Standard care

    The reference group will receive diabetes education and support by trained nurses. Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.

    Behavioral: Standard care

Interventions

  • BehavioralU-TURN

    Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated

  • BehavioralStandard care

    Standard individual diabetes support

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What researchers measure

Primary outcomes

  1. Change in Hba1c

    blood sampling of Hba1c

    Time frame: 0, 3, 6, 9, 12 months

Secondary outcomes

  1. Change in glucose lowering medication

    Change in doses of Metformin, GLP-1 analog, insulin. The change will be evaluate according to changes on the pre-specified regulation algorithm.

    Time frame: 0, 3, 6, 9, 12 months

Other outcomes

  1. incidence of hypo-glycemic episodes

    Self-report to study nurse

    Time frame: 0, 3, 6, 9, 12, 24 months

  2. Changes Ldl cholesterol

    Blod sampling

    Time frame: 0, 3, 6, 9, 12, 24 months

  3. Changes Hdl cholesterol

    Blood sampling

    Time frame: 0, 3, 6, 9, 12, 24 months

  4. Changes total cholesterol

    Blood sampling

    Time frame: 0, 3, 6, 9, 12, 24 months

  5. Changes in triglycerides

    Blood sampling

    Time frame: 0, 3, 6, 9, 12, 24 months

  6. Changes in bdnf-a

    Blood sampling

    Time frame: 0, 12 months

  7. Change in physical fitness

    Progressive treadmill protocol

    Time frame: 0, 12, 24 months

  8. Change in body composition (DXA scan)

    DXA scan

    Time frame: 0, 3, 6, 9, 12, 24 months

  9. Change in sleep quality

    Self-report using the PSQI questionnaire

    Time frame: 0, 12, months

  10. Change in sleepiness

    Self-report using the Epsworth questionnaire

    Time frame: 0, 12, months

  11. Change in sleep pattern

    Cardio-respiratory monitoring

    Time frame: 0, 12, months

  12. Change in the degree of depression

    Self-report using the BDI-II questionnaire

    Time frame: 0, 12, 24 months

  13. Change in Glucose tolerance (2-h oral glucose tolerance test)

    2-h oral glucose tolerance test

    Time frame: 0, 12, 24 months

  14. Change in Well-being

    Self-report using the questionnaire SF-36 and MFI20

    Time frame: 0, 12, 24 months

  15. Change in motivation for exercise

    Self-report using the questionnaire BREQ-2

    Time frame: 0, 12, 24 months

  16. Change in cognitive function

    Self-report using the CANTAB test battery

    Time frame: 0, 12 months

  17. Change in arterial function

    Arterial function will be determined using flow mediated dilation in a sub set of N=20 patients in each intervention arm (Total N=20)

    Time frame: 0, 12 months

  18. Partial T2D remission

    No active glucose lowering medication and HbA1c\<48 mmol/mol and Fasting blood glucose\<6,9 mmol/l

    Time frame: 24 months

  19. Full T2D remission

    No active glucose lowering medication and HbA1c\<39 mmol/mol and Fasting blood glucose\<5.6 mmol/l

    Time frame: 24 months

  20. Change in low grade inflammation

    The change in pro- and anti inflammatory markers will be evaluated

    Time frame: 0, 12, 24 months

07

Study locations

1 site
  • Center for Physical Activity Research, Copenhagen University Hospital
    Copenhagen, 2100, Denmark
08

References and documents

Publications

  • Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports. 2006 Feb;16 Suppl 1:3-63. doi: 10.1111/j.1600-0838.2006.00520.x. PubMed 16451303 ↗
  • Legaard GE, Feineis CS, Johansen MY, Hansen KB, Vaag AA, Larsen EL, Poulsen HE, Almdal TP, Karstoft K, Pedersen BK, Ried-Larsen M. Effects of an exercise-based lifestyle intervention on systemic markers of oxidative stress and advanced glycation endproducts in persons with type 2 diabetes: Secondary analysis of a randomised clinical trial. Free Radic Biol Med. 2022 Aug 1;188:328-336. doi: 10.1016/j.freeradbiomed.2022.06.013. Epub 2022 Jun 25. PubMed 35764194 ↗
  • Abildgaard J, Johansen MY, Skov-Jeppesen K, Andersen LB, Karstoft K, Hansen KB, Hartmann B, Holst JJ, Pedersen BK, Ried-Larsen M. Effects of a Lifestyle Intervention on Bone Turnover in Persons with Type 2 Diabetes: A Post Hoc Analysis of the U-TURN Trial. Med Sci Sports Exerc. 2022 Jan 1;54(1):38-46. doi: 10.1249/MSS.0000000000002776. PubMed 34431828 ↗
  • MacDonald CS, Nielsen SM, Bjorner J, Johansen MY, Christensen R, Vaag A, Lieberman DE, Pedersen BK, Langberg H, Ried-Larsen M, Midtgaard J. One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001840. doi: 10.1136/bmjdrc-2020-001840. PubMed 33441418 ↗
  • Johansen MY, Karstoft K, MacDonald CS, Hansen KB, Ellingsgaard H, Hartmann B, Wewer Albrechtsen NJ, Vaag AA, Holst JJ, Pedersen BK, Ried-Larsen M. Effects of an intensive lifestyle intervention on the underlying mechanisms of improved glycaemic control in individuals with type 2 diabetes: a secondary analysis of a randomised clinical trial. Diabetologia. 2020 Nov;63(11):2410-2422. doi: 10.1007/s00125-020-05249-7. Epub 2020 Aug 20. PubMed 32816096 ↗
  • MacDonald CS, Johansen MY, Nielsen SM, Christensen R, Hansen KB, Langberg H, Vaag AA, Karstoft K, Lieberman DE, Pedersen BK, Ried-Larsen M. Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. Mayo Clin Proc. 2020 Mar;95(3):488-503. doi: 10.1016/j.mayocp.2019.09.005. Epub 2020 Jan 30. PubMed 32007295 ↗
  • Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169. PubMed 28810024 ↗
  • Ried-Larsen M, Christensen R, Hansen KB, Johansen MY, Pedersen M, Zacho M, Hansen LS, Kofoed K, Thomsen K, Jensen MS, Nielsen RO, MacDonald C, Langberg H, Vaag AA, Pedersen BK, Karstoft K. Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial. BMJ Open. 2015 Dec 9;5(12):e009764. doi: 10.1136/bmjopen-2015-009764. PubMed 26656025 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02417012
Lead sponsor
Rigshospitalet, Denmark
Collaborators
TRYG Foundation
Responsible party
Mathias Ried-Larsen (Group leader, Rigshospitalet, Denmark) — Principal investigator
First posted
Apr 15, 2015
Start date
Apr 2015
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Dec 13, 2018

Study contacts

Mathias Ried-Larsen, PhD
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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