- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745613
Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity (HIT)
July 6, 2026 updated by: Sudip Bajpeyi, University of Texas, El Paso
Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity?
This study investigates whether: (i) a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity.
(ii) being prediabetic affects exercise induced improvements in glycemic control.
(iii) sex differences affect exercise induced improvements in glycemic control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A family history of T2D (FH+) is a risk factor for developing insulin resistance (which precedes T2D) and T2D (Ryder et al., 2003).
Exercise training on the other hand has been shown to improve insulin sensitivity and is highly effective to prevent/manage T2D.
However it is not known if early signs of insulin resistance appear before being clinically diagnosed and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of Hispanic T2D parents.
Therefore, the proposed study will determine 1) if normoglycemic (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold standard method to measure insulin sensitivity and metabolic flexibility (ability to switch between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same extent in FH+ compared to offspring of parents without family history of T2D (FH-).
This study will also determine how differently individuals with prediabetes response to exercise compared to those with normal glucose and further investigate sex differences in cardiometabolic response to exercise training.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- 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
-
-
Texas
-
El Paso, Texas, United States, 79968
- University of Texas at El Paso
-
-
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
Ages Eligible for Study
18 years to 40 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Sedentary/moderately active lifestyle
- Less than 150 minutes/wk. of structured exercise
- Physical activity level ≤ 1.4
Exclusion Criteria:
- Evidence of significant cardiovascular disease
- Screening blood pressure >140/90
- Pregnancy or breastfeeding
- Use of drugs affecting energy metabolism or body weight
- Excess alcohol, drug abuse, and smoking
- Eating disorder or eating attitudes interfering with study
- Excessively or active individuals
- Unwillingness to abide by randomization
- Injury that prevents the performance of exercise
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
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family history of T2D
The participants will undergo 8 weeks of combined exercise
|
The subjects will undergo an 8 week combined exercise intervention
|
|
Experimental: No Family history of T2D
The participants will undergo 8 weeks of combined exercise
|
The subjects will undergo an 8 week combined exercise intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin sensitivity
Time Frame: 8-weeks
|
Insulin sensitivity will be measured hyperinsulinemic -euglycemic clamp
|
8-weeks
|
|
Glycemic control (long term)
Time Frame: 8-weeks
|
Glycated hemoglobin (HbA1c) will be measured from whole blood with a bench top chemistry analyzer
|
8-weeks
|
|
Glycemic control (postprandial)
Time Frame: 8-weeks
|
Postprandial glycemic control will be measured by an oral glucose tolerance test (OGTT)
|
8-weeks
|
|
Glycemic variability
Time Frame: 8-weeks
|
Glycemic variability will be assessed with glucose monitoring
|
8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cellular mitochondria function
Time Frame: 8-weeks
|
Cellular oxygen consumption of peripheral blood mononuclear cells (PBMC) will be measured with seahorse analyzer.
|
8-weeks
|
|
Cytokines
Time Frame: 8-weeks
|
Interleukin (IL)-6 will be measured with enzyme-linked immunosorbent assay
|
8-weeks
|
|
Blood gene expression markers of glycemic control
Time Frame: 8-weeks
|
Blood microRNAs of glycemic control will be measured with quantitative polymerase chain reaction.
|
8-weeks
|
|
Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism
Time Frame: 8-weeks
|
Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism will assessed with flow cytometry.
|
8-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sudip Bajpeyi, PhD., University of Texas, El Paso
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
April 1, 2016
Primary Completion (Actual)
May 1, 2026
Study Completion (Actual)
May 1, 2026
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimated)
April 20, 2016
Study Record Updates
Last Update Posted (Actual)
July 7, 2026
Last Update Submitted That Met QC Criteria
July 6, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 755513-1
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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