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

April 13, 2023 updated by: AdventHealth Translational Research Institute
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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AdventHealth Translational Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIMDFH 1144866

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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