NCT02745613

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

10.1 years

First QC Date

April 18, 2016

Last Update Submit

July 6, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Insulin sensitivity

    Insulin sensitivity will be measured hyperinsulinemic -euglycemic clamp

    8-weeks

  • Glycemic control (long term)

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

    8-weeks

  • Glycemic control (postprandial)

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

    8-weeks

  • Glycemic variability

    Glycemic variability will be assessed with glucose monitoring

    8-weeks

Secondary Outcomes (4)

  • Cellular mitochondria function

    8-weeks

  • Cytokines

    8-weeks

  • Blood gene expression markers of glycemic control

    8-weeks

  • Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism

    8-weeks

Study Arms (2)

Family history of T2D

EXPERIMENTAL

The participants will undergo 8 weeks of combined exercise

Other: 8 weeks of combined exercise intervention

No Family history of T2D

EXPERIMENTAL

The participants will undergo 8 weeks of combined exercise

Other: 8 weeks of combined exercise intervention

Interventions

The subjects will undergo an 8 week combined exercise intervention

Family history of T2DNo Family history of T2D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary/moderately active lifestyle
  • Less than 150 minutes/wk. of structured exercise
  • Physical activity level ≤ 1.4

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at El Paso

El Paso, Texas, 79968, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sudip Bajpeyi, PhD.

    University of Texas, El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations