- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977442
Dynamics of Muscle Mitochondria in Type 2 Diabetes Exercise (DYNAMMO-T2DEX)
Dynamics of Muscle Mitochondria in Type 2 Diabetes
Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes.
Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes.
This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher Axelrod
- Phone Number: 225-763-3171
- Email: Christopher.Axelrod@pbrc.edu
Study Contact Backup
- Name: John Kirwan
- Email: John.Kirwan@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 2 Diabetes
- Body Mass Index (BMI) between 25 and 50 kg/m2
- HbA1C < 10%
- Sedentary
Exclusion Criteria:
- Evidence of type 1 diabetes or requiring insulin therapy
- BMI >50 kg/m2
- Smoking
- Active pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
12 week exercise program, 5 days/week, 60 min/day
|
|
No Intervention: standard of care
12 week standard of care recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of exercise on mitochondrial dynamics
Time Frame: 5 years
|
Dynamics will be assessed from quantitative measures of dynamin-related protein-1.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of exercise on mitochondrial function
Time Frame: 5 years
|
Function will be assessed from oxygen consumption.
|
5 years
|
Insulin sensitivity
Time Frame: 5 years
|
Insulin sensitivity will be assessed by euglycemic hyperinsulinemic clamp.
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: John Kirwan, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2018-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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