The Insulin Sensitivity Using Aerobic Interval Conditioning

NCT01286922 | Completed DMC

• 2 other identifiers: PBRC 29018R56DK081807
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-diabetes

Keywords

diabetes; exercise; insulin resistance; interval training; physical activity

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.

  3 months

Secondary Outcomes (1)

• Cardiorespiratory Fitness

  3 months

Study Arms (2)

Interval Training

EXPERIMENTAL

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

Aerobic Conditioning

PLACEBO COMPARATOR

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

Interventions

Behavioral: exercise OTHER

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.

Aerobic Conditioning; Interval Training

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (16)

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  PMID: 12610015 BACKGROUND

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  PMID: 9694838 BACKGROUND

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  PMID: 7597034 BACKGROUND

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  PMID: 1617788 BACKGROUND

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  PMID: 17762377 BACKGROUND

• Earnest CP, Lupo M, Thibodaux J, Hollier C, Butitta B, Lejeune E, Johannsen NM, Gibala MJ, Church TS. Interval training in men at risk for insulin resistance. Int J Sports Med. 2013 Apr;34(4):355-63. doi: 10.1055/s-0032-1311594. Epub 2012 Nov 23.

  PMID: 23180210 RESULT

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperinsulinism

Study Officials

• Conrad P. Earnest, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Timothy S. Church, MD, MPH, PhD

  Pennington Biomedical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: January 31, 2011
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (1)