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

NCT03379792 | Completed Results DMC

• 1 other identifier: TRIMDFH 1144866
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Obesity; Overweight

Outcome Measures

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.

  24 hours

Study Arms (6)

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.

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Males and females, 19 to 30 years of age, inclusive.
• Type 1 Diabetes Cohort:
• Diagnosis of type 1 diabetes for greater than 1 year at screening.
• Hemoglobin A1c 6.5-13% or
• Control Cohort Without Diabetes:
• a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender
• Able to provide informed consent.
• BMI 18-39.9 kg/m\^2

You may not qualify if:

• Type 2 diabetes
• 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)
• Liver disease (AST or ALT \>2.5 times the upper limit of normal), history of hepatitis
• Kidney disease (creatinine \>1.6 mg/dl or estimated glomerular filtration rate (GFR)\<60 ml/min)
• Dyslipidemia, including triglycerides \>800 mg/dl, LDL \>200 mg/dl
• Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women)
• Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic)
• Uncontrolled hypertension (BP \>160 mmHg systolic or \> 100mmHg diastolic)
• History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
• 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)
• History of organ transplant
• History of HIV, active Hepatitis B or C, or Tuberculosis
• Pregnancy, lactation or 6 months postpartum from screening visit
• History of major depression
• Psychiatric disease prohibiting adherence to study protocol

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (11)

• 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.

  PMID: 25998289 BACKGROUND

• 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.

  PMID: 25413942 BACKGROUND

• 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.

  PMID: 20820753 BACKGROUND

• 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.

  PMID: 19636033 BACKGROUND

• 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.

  PMID: 16776747 BACKGROUND

• 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.

  PMID: 15207844 BACKGROUND

• 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.

  PMID: 8243815 BACKGROUND

• 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.

  PMID: 8586779 BACKGROUND

• 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.

  PMID: 6147290 BACKGROUND

• 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.

  PMID: 37576973 DERIVED

• 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.

  PMID: 35460915 DERIVED

Related Links

• Translational Research Institute for Metabolism and Diabetes

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard E. Pratley
• Organization: AdventHealth Translational Research Institute

richard.pratley.md@adventhealth.com

407-303-2519

Study Officials

• Richard Pratley, MD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

• Elizabeth Mayer-Davis, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• David M Maahs, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 20, 2017
• Study Start: March 8, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-04

Locations

US (1)