NCT02977442

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

November 28, 2016

Last Update Submit

April 24, 2025

Conditions

Keywords

Mitochondrial DynamicsInsulin ResistanceExercise and Diabetes

Outcome Measures

Primary Outcomes (1)

  • Effects of exercise on mitochondrial dynamics

    Dynamics will be assessed from quantitative measures of dynamin-related protein-1.

    5 years

Secondary Outcomes (2)

  • Effects of exercise on mitochondrial function

    5 years

  • Insulin sensitivity

    5 years

Study Arms (2)

exercise

EXPERIMENTAL

12 week exercise program, 5 days/week, 60 min/day

Behavioral: exercise

standard of care

NO INTERVENTION

12 week standard of care recommendations

Interventions

exerciseBEHAVIORAL
exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 Diabetes
  • Body Mass Index (BMI) between 25 and 50 kg/m2
  • HbA1C \< 10%
  • Sedentary

You may not qualify if:

  • Evidence of type 1 diabetes or requiring insulin therapy
  • BMI \>50 kg/m2
  • Smoking
  • Active pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John Kirwan, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2023

Study Completion

January 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations