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The Insulin Sensitivity Using Aerobic Interval Conditioning (ISAIC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01286922
First received: January 28, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Pre-diabetes
Other: Behavioral: exercise
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Insulin Sensitivity Using Aerobic Interval Conditioning

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.


Secondary Outcome Measures:
  • Cardiorespiratory Fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.


Enrollment: 42
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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."

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286922

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Conrad P. Earnest, PhD Pennington Biomedical Research Center
Study Director: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
  More Information

Publications:

Responsible Party: Timothy Church, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01286922     History of Changes
Other Study ID Numbers: PBRC29018, R56DK081807
Study First Received: January 28, 2011
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Pennington Biomedical Research Center:
diabetes
exercise
insulin resistance
interval training
physical activity

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014