NCT02745613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration 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
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

April 18, 2016

Last Update Submit

January 28, 2020

Conditions

Insulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    8 weeks

Secondary Outcomes (1)

  • Myokine concentrations

    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

8 weeks of combined exercise interventionOTHER

The subjects will undergo an 8 week combined exercise intervention

Family history of T2DNo Family history of T2D

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ Age ≤ 40 years
  • ≤ 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

You may not qualify if:

  • 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

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
Associate Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

US(1)