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

Primary Purpose

Insulin Sensitivity/Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8 weeks of combined exercise intervention
Sponsored by
University of Texas, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Insulin Sensitivity/Resistance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas at El Paso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Family history of T2D

No Family history of T2D

Arm Description

The participants will undergo 8 weeks of combined exercise

The participants will undergo 8 weeks of combined exercise

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Myokine concentrations

Full Information

First Posted
April 18, 2016
Last Updated
January 28, 2020
Sponsor
University of Texas, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT02745613
Brief Title
Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity
Acronym
HIT
Official Title
Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity in a Hispanic Population?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas, El Paso

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity/Resistance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family history of T2D
Arm Type
Experimental
Arm Description
The participants will undergo 8 weeks of combined exercise
Arm Title
No Family history of T2D
Arm Type
Experimental
Arm Description
The participants will undergo 8 weeks of combined exercise
Intervention Type
Other
Intervention Name(s)
8 weeks of combined exercise intervention
Intervention Description
The subjects will undergo an 8 week combined exercise intervention
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Myokine concentrations
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudip Bajpeyi, PhD.
Organizational Affiliation
University of Texas, El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79968
Country
United States

12. IPD Sharing Statement

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Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity

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