Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity (HIT)

January 28, 2020 updated by: Sudip Bajpeyi, University of Texas, El Paso

Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity in a Hispanic Population?

This study investigates weather a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity in the hispanic population

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-).

Study Type

Interventional

Enrollment (Anticipated)

24

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

  • 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

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 18 ≤ Age ≤ 40 years
  • 18 ≤ BMI ≤ 30 kg/m2
  • Both parents are Mexican/Mexican-American)
  • Sedentary lifestyle
  • Less than 60 minutes/wk. of structured exercise
  • Physical activity level ≤ 1.4

Exclusion Criteria:

  • Evidence of significant cardiovascular disease or diabetes
  • A fasting blood glucose ≥100 mg/dL
  • Screening blood pressure >140/90
  • Hyperlipidemia
  • Use of drugs affecting energy metabolism or body weight
  • Excess alcohol, drug abuse, and smoking
  • Eating disorder or eating attitudes interfering with study
  • Unwillingness to be abide by randomization

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
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

Outcome Measure
Time Frame
Insulin sensitivity
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Myokine concentrations
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas, El Paso

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, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

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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