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

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.

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

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.
Interventional

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.
50

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
    • 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

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Family history of T2D
The participants will undergo 8 weeks of combined exercise
Other: 8 weeks of combined exercise intervention
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
Other: 8 weeks of combined exercise intervention
The subjects will undergo an 8 week combined exercise intervention

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas, El Paso

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: 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

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.
April 1, 2016

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.
May 1, 2026

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.
May 1, 2026

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).
April 18, 2016

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.
April 19, 2016

First Posted (Estimated)

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.
April 20, 2016

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.
July 7, 2026

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.
July 6, 2026

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.
July 1, 2026

More Information

Terms related to this study

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.
  • 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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