CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Behavioral: exerciseother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01286922
NCT01286922N/ACompleted

The Insulin Sensitivity Using Aerobic Interval Conditioning

Pennington Biomedical Research Center·interventional·Posted Jan 31, 2011·Updated Sep 15, 2022

In Brief

A clinical study evaluating Behavioral: exercise for Pre-diabetes. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3 months of monitored exercise using a randomly assisgned design where participants will exercise under either AER or INT training conditions. The AER training condition will be consistent with "standard-of-care" recommendations. Exercise training will entail one 3-month blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period, 2) 1-month of traditional aerobic training and 3) 1-month of either continued AER or INT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-diabetes
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.4 years ago

Interventions

Behavioral: exerciseother

Specific Aim: We will identify, recruit, assess, and randomly assign 42 sedentary, overweight-obese individuals who are at risk for pre-diabetes to an AER or INT training group in order to test the hypothesis: • Individuals randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER. Secondary Aim: We will measure maximal cardiorespiratory fitness (VO2max/peak) in order to test the hypothesis: • Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.