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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379792
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
AdventHealth Translational Research Institute

Brief Summary:
The purpose of this study is to compare the metabolic phenotype of a range of body weights in individuals with and without Type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Other: DEXA Other: MRI Other: CGM Other: Whole room calorimeters Other: Dietary counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Actual Study Start Date : March 8, 2018
Actual Primary Completion Date : July 20, 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Lean T1D Other: DEXA
Measurement of body composition by Dual Energy X-ray Absorptiometry (DEXA)

Other: MRI
Whole body magnetic resonance imaging (MRI)

Other: CGM
A continuous glucose monitor (CGM) will be placed on the participant and will be used as a safety measure to monitor glucose levels.

Other: Whole room calorimeters
Whole room indirect calorimetry allows for the simultaneous measure of total energy expenditure and substrate oxidation in a free living environment with multiple activities.

Active Comparator: Obese T1D Other: Whole room calorimeters
Whole room indirect calorimetry allows for the simultaneous measure of total energy expenditure and substrate oxidation in a free living environment with multiple activities.

Other: Dietary counseling
The low carbohydrate diet counseling will be to assist young adult, overweight study participants with Type 1 diabetes in adhering to a lower calorie diet (500 calorie deficit)

Active Comparator: Non-diabetic Other: DEXA
Measurement of body composition by Dual Energy X-ray Absorptiometry (DEXA)

Other: MRI
Whole body magnetic resonance imaging (MRI)

Other: CGM
A continuous glucose monitor (CGM) will be placed on the participant and will be used as a safety measure to monitor glucose levels.

Other: Whole room calorimeters
Whole room indirect calorimetry allows for the simultaneous measure of total energy expenditure and substrate oxidation in a free living environment with multiple activities.




Primary Outcome Measures :
  1. Whole Room Calorimetry [ Time Frame: 24 hours ]
    Compare 24-hour energy expenditure in patients with T1D and healthy normal volunteers that accounts for differences in hyperglycemia and body composition. 24-hour energy expenditure in kcal/24 hours after adjusting for differences in hyperglycemia (CGM) and body composition (DXA). These parameters will be measured by VO2, VC02, and urinary nitrogen.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females, 19 to 30 years of age, inclusive.
  2. Type 1 Diabetes Cohort:

    • Diagnosis of type 1 diabetes for greater than 1 year at screening.
    • Hemoglobin A1c 6.5-13% or
  3. Non-Diabetic Control Cohort:

    • Healthy individuals (non-diabetic) matched to T1D cohort by BMI, and gender

3. Able to provide informed consent. 4. BMI 18-39

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379792


Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
AdventHealth Translational Research Institute
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by AdventHealth Translational Research Institute:
Informed Consent Form  [PDF] December 13, 2018

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier: NCT03379792    
Other Study ID Numbers: TRIMDFH 1144866
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AdventHealth Translational Research Institute:
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight