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OpenTrials
Completed

NCT Number: NCT02745613

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at El Paso

El Paso, Texas, 79968, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8 weeks of combined exercise intervention

Other

The subjects will undergo an 8 week combined exercise intervention

Primary outcomes

  1. Insulin sensitivity

    Time frame: 8-weeks

    Insulin sensitivity will be measured hyperinsulinemic -euglycemic clamp

  2. Glycemic control (long term)

    Time frame: 8-weeks

    Glycated hemoglobin (HbA1c) will be measured from whole blood with a bench top chemistry analyzer

  3. Glycemic control (postprandial)

    Time frame: 8-weeks

    Postprandial glycemic control will be measured by an oral glucose tolerance test (OGTT)

  4. Glycemic variability

    Time frame: 8-weeks

    Glycemic variability will be assessed with glucose monitoring

Secondary outcomes

  1. Cellular mitochondria function

    Time frame: 8-weeks

    Cellular oxygen consumption of peripheral blood mononuclear cells (PBMC) will be measured with seahorse analyzer.

  2. Cytokines

    Time frame: 8-weeks

    Interleukin (IL)-6 will be measured with enzyme-linked immunosorbent assay

  3. Blood gene expression markers of glycemic control

    Time frame: 8-weeks

    Blood microRNAs of glycemic control will be measured with quantitative polymerase chain reaction.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Texas, El Paso

Other

Registry information

Official study title

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

Acronym: HIT

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2016
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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