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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Expenditure
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth Mayer-Davis, PhD, UNC Chapel Hill
  • Principal Investigator: David M Maahs, MD, PhD, Stanford University
  • Principal Investigator: Richard Pratley, MD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Actual)

July 20, 2020

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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