The Insulin Sensitivity Using Aerobic Interval Conditioning (ISAIC)

September 13, 2022 updated by: Pennington Biomedical Research Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is currently estimated that type II diabetes (T2D) affects 5-8% of adults. Also recognized is a transitional group of individuals whose control of blood glucose is abnormal, but not yet considered diabetic. These individuals are classified as having pre-diabetes, which is defined as having impaired fasting glucose (IFG;fasting glucose 100-125 mg/dl), impaired glucose tolerance (IGT; post 2-h glucose load; 140-199 mg/dl) or both. This population represents a significant segment of the population as it is estimated that approximately 23% of Americans have pre-diabetes (IGT or IFG). Two unifying features associated with these metabolic impairments is a strong link to obesity and physical inactivity. Regular exercise positively influences IFG/IGT and obesity, and represents an important therapy for preventing the progression to T2D by enhancing several mechanisms of action including improved: glucose metabolism, muscle respiratory capacity, mitochondrial respiratory chain activity and ß-oxidation. Importantly, the dose of physical activity required to promote metabolic benefits appears to be obtainable for most individuals with as little as ~1000 kcal/w of aerobic activity.

While most exercise policy statement guidelines recommend that exercise be performed within an intensity ranging of 40-85% V02max, newer guidelines, such as the recently updated Physical Activity and Public Health Recommendations recognize that few studies have examined the effects of intensity, duration, or frequency of physical activity independent of their contribution to the total amount of physical activity. Accordingly, this writing group specifically recommended that, "based on recent data, there is some indication that vigorous-intensity activities may have greater benefit for reducing cardiovascular disease and premature mortality than moderate-intensity physical activity .... that much more work is needed is this area."

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age 30 to 60 years, inclusive
  • BMI greater than or equal to 25 - less than or equal to 35 kg/m2
  • Waist circumference >38"; Waist-to-Hip Ratio >0.95 Sedentary Lifestvle
  • Not physically active greater than or equal to 3 days/week-l for 20 min each time for the previous 6 months,
  • Not participating in regular resistance exercise

Exclusion Criteria:

  • Resting blood pressure greater than or equal to 160/100 mm Hg
  • Triglycerides greater than or equal to 500 mg/dL
  • Factors that may limit adherence to intervention or affect conduct of the trial such as lack of time, amount of travel, and/or work or family stressors
  • Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
  • Failure to complete behavioral run-in and baseline testing
  • Hospitalization for depression in the last 6 months
  • Not physically capable of performing the exercise required of the study protocols
  • Consuming >14 alcoholic beverages per week
  • Plans to be away >4 weeks in the next 6 months
  • Lack of support from primary health care provider or family members
  • Signficant weight loss in the past year (>20 kg) or current use of weight loss medications
  • Current diagnsis of schizophrenia, or other psychotic disorders, or bipolar disorder
  • Another member of household is a participant or staff member of the study.
  • History of bariatric surgery within last 3 years,
  • Other temporary intervening event, such as sick spouse, bereavement, or recent move.
  • Other medical, psychiatric, or behavioral limitations that in the view of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
  • Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
  • Cancers requiring treatment in the past 5 years, unless prognosis is excellent.
  • Self-report HIV or tuberculosis.
  • History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation.
  • Renal disease: currently receiving dialysis.
  • Type I diabetes mellitus
  • Type 2 diabetes mellitus, defined as:

Fasting plasma glucose levels greater than or equal to 26 mg/dL 2-hour postprandial Oral Glucose Tolerance Test results greater than or equal to 200 mg/dL

  • Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
  • Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol.
  • Advanced neuropathy or retinopathy.
  • Smoker or have used nicotine/tobacco products within the last 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interval Training
The target intensity for the INT group is 2 min at about 95% of baseline VO2max followed by 2 min of recovery at 40-50% of VO2max. Regardless of the training method each participant will be "locked" into a weekly energy expenditure of 12 kilocalories per kilogram of body weight per week (KKW).
Other: Behavioral: exercise

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.
Placebo Comparator: Aerobic Conditioning
During the first AER training condition, we will train all participants at an energy expenditure of 12 kcal/kg/wk (KKW). The target exercise intensity for the AER group will be 50%-70% of baseline V02max.
Other: Behavioral: exercise

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: 3 months
Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory Fitness
Time Frame: 3 months
Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Conrad P. Earnest, PhD, Pennington Biomedical Research Center
  • Study Director: Timothy S. Church, MD, MPH, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 29018
  • R56DK081807 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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