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CompletedNCT03379792ACMEUpdated Jan 5, 2024Results posted

The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes

An observational study in Type 1 Diabetes, sponsored by AdventHealth Translational Research Institute. Completed at 1 site in United States. Open to participants aged 19 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by AdventHealth Translational Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
32
Ages
19 Years to 30 Years
Sex
All
01

Study summary

The purpose of this study is to measure the metabolic phenotype of a range of body weights in individuals with and without type 1 diabetes.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Obesity
  • Overweight
03

Who can participate

Ages eligible
19 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Young adults with type 1 diabetes diagnosed greater than or equal to 1 year prior to screening, or control young adults without diabetes, both within a range of BMI classifications (18-39.9 kg/m\^2).

Inclusion criteria

  1. Males and females, 19 to 30 years of age, inclusive.

  2. Type 1 Diabetes Cohort:

    1. Diagnosis of type 1 diabetes for greater than 1 year at screening.
    2. Hemoglobin A1c 6.5-13% or

    Control Cohort Without Diabetes:

    a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender

  3. Able to provide informed consent.
  4. BMI 18-39.9 kg/m\^2

Exclusion criteria

Exclusion Criteria:

  1. Type 2 diabetes
  2. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)
  3. Liver disease (AST or ALT >2.5 times the upper limit of normal), history of hepatitis
  4. Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate (GFR)\<60 ml/min)
  5. Dyslipidemia, including triglycerides >800 mg/dl, LDL >200 mg/dl
  6. Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women)
  7. Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH \<10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
  8. Uncontrolled hypertension (BP >160 mmHg systolic or > 100mmHg diastolic)
  9. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
  10. Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone, birth control or estrogen replacement therapy)
  11. History of organ transplant
  12. History of HIV, active Hepatitis B or C, or Tuberculosis
  13. Pregnancy, lactation or 6 months postpartum from screening visit
  14. History of major depression
  15. Psychiatric disease prohibiting adherence to study protocol
  16. History of eating disorders
  17. Cushing's disease or syndrome
  18. History of bariatric surgery
  19. Tobacco use within the past 3 months
  20. History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years
  21. Use of oral or injectable anti-hyperglycemic agents (except insulin)
  22. Current use of beta-adrenergic blocking agents
  23. Use of antibiotics within the past 3 months
  24. Weight >450 lbs (This is DEXA table weight limit)
  25. Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening
  26. Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening
  27. Participants with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies, or allergies to food we will provide them during the study)
  28. Gastrointestinal disorders including: inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis.
  29. Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete study visits
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • Type 1 Diabetes: BMI Classified as Lean

    Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2.

  • Type 1 Diabetes: BMI Classified as Overweight

    Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.

  • Type 1 Diabetes: BMI Classified as Obese

    Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.

  • Control: BMI Classified as Lean

    Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.

  • Control: BMI Classified as Overweight

    Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.

  • Control: BMI Classified as Obese

    Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.

05

What researchers measure

Primary outcomes

  1. Energy Expenditure

    Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.

    Time frame: 24 hours

06

Results

Posted Jan 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneType 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as Obese
Started695444
Completed695333
Not completed000111
Withdrew: Physician decision000100
Withdrew: Withdrawal by subject000011

Outcome measures

PrimaryEnergy Expenditure

Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.

Time frame:
24 hours
Reported as:
Mean · Kilocalories
Energy Expenditure
KilocaloriesType 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as Obese
Energy Expenditure1978.3 ± 337.81969.8 ± 236.32414.8 ± 419.11497.7 ± 123.61902.0 ± 406.02671.3 ± 402.7
Statistical analysis
  • Type 1 Diabetes: BMI Classified as Lean vs Control: BMI Classified as Lean · t-test, 2 sided · p = 0.24
  • Type 1 Diabetes: BMI Classified as Overweight vs Control: BMI Classified as Overweight · t-test, 2 sided · p = 0.22
  • Type 1 Diabetes: BMI Classified as Obese vs Control: BMI Classified as Obese · t-test, 2 sided · p = 1.0

Adverse events

Collected over 28-42 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Type 1 Diabetes: BMI Classified as Lean0/6 (0%)0/6 (0%)2/6 (33.3%)
Type 1 Diabetes: BMI Classified as Overweight0/9 (0%)0/9 (0%)5/9 (55.6%)
Type 1 Diabetes: BMI Classified as Obese0/5 (0%)0/5 (0%)1/5 (20%)
Control: BMI Classified as Lean0/4 (0%)0/4 (0%)0/4 (0%)
Control: BMI Classified as Overweight0/4 (0%)0/4 (0%)0/4 (0%)
Control: BMI Classified as Obese0/4 (0%)0/4 (0%)0/4 (0%)
Most frequent other events
Most frequent other events
EventType 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as Obese
HeadacheNervous system disorders2/62/90/50/40/40/4
VomitingGastrointestinal disorders0/60/91/50/40/40/4
RhinorrheaRespiratory, thoracic and mediastinal disorders0/60/91/50/40/40/4
NauseaGastrointestinal disorders0/61/91/50/40/40/4
Sore ThroatRespiratory, thoracic and mediastinal disorders0/61/90/50/40/40/4
HypoglycemiaMetabolism and nutrition disorders0/61/90/50/40/40/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)Type 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as ObeseTotal
Mean22.1 ± 1.924.6 ± 3.225.8 ± 3.524.3 ± 3.324.0 ± 2.127.8 ± 6.124.6 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)Type 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as ObeseTotal
Female44231115
Male25313317
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Type 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as ObeseTotal
Hispanic or Latino26112214
Not Hispanic or Latino33422216
Unknown or Not Reported1001002
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Type 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as ObeseTotal
American Indian or Alaska Native0000000
Asian0001001
Native Hawaiian or Other Pacific Islander0100001
Black or African American0121116
White56323322
More than one race0000000
Unknown or Not Reported1100002
Region of Enrollment
Region of Enrollment(participants)Type 1 Diabetes: BMI Classified as LeanType 1 Diabetes: BMI Classified as OverweightType 1 Diabetes: BMI Classified as ObeseControl: BMI Classified as LeanControl: BMI Classified as OverweightControl: BMI Classified as ObeseTotal
United States69544432
07

Study locations

1 site
  • Translational Research Institute for Metabolism and Diabetes
    Orlando, Florida 32804, United States
08

References and documents

Publications

  • Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078. PubMed 25998289 ↗
  • Chillaron JJ, Benaiges D, Mane L, Pedro-Botet J, Flores Le-Roux JA. Obesity and type 1 diabetes mellitus management. Minerva Endocrinol. 2015 Mar;40(1):53-60. Epub 2014 Nov 21. PubMed 25413942 ↗
  • Maahs DM, Ogden LG, Dabelea D, Snell-Bergeon JK, Daniels SR, Hamman RF, Rewers M. Association of glycaemia with lipids in adults with type 1 diabetes: modification by dyslipidaemia medication. Diabetologia. 2010 Dec;53(12):2518-25. doi: 10.1007/s00125-010-1886-6. Epub 2010 Sep 4. PubMed 20820753 ↗
  • Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193. PubMed 19636033 ↗
  • Jacob AN, Salinas K, Adams-Huet B, Raskin P. Potential causes of weight gain in type 1 diabetes mellitus. Diabetes Obes Metab. 2006 Jul;8(4):404-11. doi: 10.1111/j.1463-1326.2005.00515.x. Erratum In: Diabetes Obes Metab. 2006 Jul;8(4):472. PubMed 16776747 ↗
  • Rigalleau V, Lasseur C, Pecheur S, Chauveau P, Combe C, Perlemoine C, Baillet L, Gin H. Resting energy expenditure in uremic, diabetic, and uremic diabetic subjects. J Diabetes Complications. 2004 Jul-Aug;18(4):237-41. doi: 10.1016/S1056-8727(03)00077-1. PubMed 15207844 ↗
  • Carlson MG, Campbell PJ. Intensive insulin therapy and weight gain in IDDM. Diabetes. 1993 Dec;42(12):1700-7. doi: 10.2337/diab.42.12.1700. PubMed 8243815 ↗
  • Greco AV, Tataranni PA, Mingrone G, De Gaetano A, Manto A, Cotroneo P, Ghirlanda G. Daily energy metabolism in patients with type 1 diabetes mellitus. J Am Coll Nutr. 1995 Jun;14(3):286-91. doi: 10.1080/07315724.1995.10718509. PubMed 8586779 ↗
  • Nair KS, Halliday D, Garrow JS. Increased energy expenditure in poorly controlled Type 1 (insulin-dependent) diabetic patients. Diabetologia. 1984 Jul;27(1):13-6. doi: 10.1007/BF00253494. PubMed 6147290 ↗
  • Corbin KD, Igudesman D, Addala A, Casu A, Crandell J, Kosorok MR, Maahs DM, Pokaprakarn T, Pratley RE, Souris KJ, Thomas JM, Zaharieva DP, Mayer-Davis EJ; ACT1ON Consortium. Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes. Contemp Clin Trials. 2022 Jun;117:106765. doi: 10.1016/j.cct.2022.106765. Epub 2022 Apr 20. PubMed 35460915 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 23, 2019
  • Informed consent form · Oct 23, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03379792
Lead sponsor
AdventHealth Translational Research Institute
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Mar 8, 2018
Primary completion
Jul 20, 2020
Completion
Jul 20, 2020
Results posted
Jan 5, 2024
Last update
Jan 5, 2024

Study contacts

Richard Pratley, MD
principal investigator · Translational Research Institute for Metabolism and Diabetes
Elizabeth Mayer-Davis, PhD
principal investigator · UNC Chapel Hill
David M Maahs, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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