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

Type 1 Diabetes Clinical Trial

— ACME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379792
• Other study ID #: TRIMDFH 1144866
• Status: Completed
• Start date: March 8, 2018
• Est. completion date: July 20, 2020

Study information

• Verified date: April 2023
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Obesity
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours

External Links

•   Translational Research Institute for Metabolism and Diabetes