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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02745613
Other study ID # 755513-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date May 2019

Study information

Verified date January 2020
Source University of Texas, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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-).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
8 weeks of combined exercise intervention
The subjects will undergo an 8 week combined exercise intervention

Locations

Country Name City State
United States University of Texas at El Paso El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin sensitivity 8 weeks
Secondary Myokine concentrations 8 weeks
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