Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D) (DYNAMMO-T2D)
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|ClinicalTrials.gov Identifier: NCT02697201|
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : July 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Drug: Intralipid Drug: Saline||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO-T2D)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: Intralipid Infusion, then Saline
Participants in this arm will first receive a lipid infusion. Then 4 weeks later the saline infusion.
Other Name: Liposyn
0.55 ml/kg/h for
Sham Comparator: Saline Infusion, then Intralipid
Participants in this arm will first receive a saline infusion. Then 4 weeks later the lipid infusion.
Other Name: Liposyn
0.55 ml/kg/h for
- Effects of lipid infusion on mitochondrial fission [ Time Frame: 5 years ]Fission will be assessed from quantitative measures of dynamin-related protein-1. The unit of assessment is arbitrary units of blot intensity and is expressed as AU.
- Effects of lipid infusion on mitochondrial function [ Time Frame: 5 years ]Function will be assessed from oxygen consumption. Unit of assessment is pmol/s/mg of muscle.
- Insulin sensitivity [ Time Frame: 5 years ]Insulin sensitivity will be assessed by euglycemic hyperinsulinemic clamp. Units of assessment are mg/kg/min.
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): NCT02697201
|Contact: Christopher Axelrod, MEd||225-763-3171||Christopher.Axelrod@pbrc.edu|
|Contact: John P Kirwan, Ph.D.||216-444-3412||John.Kirwan@pbrc.edu|
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: John Kirwan John.Kirwan@pbrc.edu|
|Contact: Christopher Axelrod Christopher.Axelrod@pbrc.edu|
|Principal Investigator:||John P Kirwan, Ph.D.||Pennington Biomedical Research Center|