The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
NCT ID: NCT03379792
Last Updated: 2024-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
32 participants
OBSERVATIONAL
2018-03-08
2020-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Type 1 Diabetes: BMI Classified as Lean
Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2.
No interventions assigned to this group
Type 1 Diabetes: BMI Classified as Overweight
Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2.
No interventions assigned to this group
Type 1 Diabetes: BMI Classified as Obese
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2.
No interventions assigned to this group
Control: BMI Classified as Lean
Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2.
No interventions assigned to this group
Control: BMI Classified as Overweight
Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2.
No interventions assigned to this group
Control: BMI Classified as Obese
Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
30 Years
ALL
Yes
Sponsors
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AdventHealth Translational Research Institute
OTHER
Responsible Party
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Principal Investigators
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Richard Pratley, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Elizabeth Mayer-Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Chapel Hill
David M Maahs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Casu A, Nunez Lopez YO, Yu G, Clifford C, Bilal A, Petrilli AM, Cornnell H, Carnero EA, Bhatheja A, Corbin KD, Iliuk A, Maahs DM, Pratley RE. The proteome and phosphoproteome of circulating extracellular vesicle-enriched preparations are associated with characteristic clinical features in type 1 diabetes. Front Endocrinol (Lausanne). 2023 Jul 28;14:1219293. doi: 10.3389/fendo.2023.1219293. eCollection 2023.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Translational Research Institute for Metabolism and Diabetes
Other Identifiers
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TRIMDFH 1144866
Identifier Type: -
Identifier Source: org_study_id
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