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The Insulin Sensitivity Using Aerobic Interval Conditioning (ISAIC)

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: exercise
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes focused on measuring diabetes, exercise, insulin resistance, interval training, physical activity

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interval Training

Aerobic Conditioning

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiorespiratory Fitness
Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.

Full Information

First Posted
January 28, 2011
Last Updated
September 13, 2022
Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01286922
Brief Title
The Insulin Sensitivity Using Aerobic Interval Conditioning
Acronym
ISAIC
Official Title
The Insulin Sensitivity Using Aerobic Interval Conditioning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
diabetes, exercise, insulin resistance, interval training, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interval Training
Arm Type
Experimental
Arm Description
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).
Arm Title
Aerobic Conditioning
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behavioral: exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cardiorespiratory Fitness
Description
Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad P. Earnest, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy S. Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9571335
Citation
Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
Results Reference
background
PubMed Identifier
12502614
Citation
Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S5-20. doi: 10.2337/diacare.26.2007.s5. No abstract available.
Results Reference
background
PubMed Identifier
17192378
Citation
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
Results Reference
background
PubMed Identifier
12610015
Citation
Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.
Results Reference
background
PubMed Identifier
9694838
Citation
Zierath JR, Tsao TS, Stenbit AE, Ryder JW, Galuska D, Charron MJ. Restoration of hypoxia-stimulated glucose uptake in GLUT4-deficient muscles by muscle-specific GLUT4 transgenic complementation. J Biol Chem. 1998 Aug 14;273(33):20910-5. doi: 10.1074/jbc.273.33.20910.
Results Reference
background
PubMed Identifier
7597034
Citation
Lund S, Holman GD, Schmitz O, Pedersen O. Contraction stimulates translocation of glucose transporter GLUT4 in skeletal muscle through a mechanism distinct from that of insulin. Proc Natl Acad Sci U S A. 1995 Jun 20;92(13):5817-21. doi: 10.1073/pnas.92.13.5817.
Results Reference
background
PubMed Identifier
9435517
Citation
Hayashi T, Wojtaszewski JF, Goodyear LJ. Exercise regulation of glucose transport in skeletal muscle. Am J Physiol. 1997 Dec;273(6):E1039-51. doi: 10.1152/ajpendo.1997.273.6.E1039.
Results Reference
background
PubMed Identifier
1319676
Citation
Turcotte LP, Richter EA, Kiens B. Increased plasma FFA uptake and oxidation during prolonged exercise in trained vs. untrained humans. Am J Physiol. 1992 Jun;262(6 Pt 1):E791-9. doi: 10.1152/ajpendo.1992.262.6.E791.
Results Reference
background
PubMed Identifier
8271208
Citation
Kiens B, Essen-Gustavsson B, Christensen NJ, Saltin B. Skeletal muscle substrate utilization during submaximal exercise in man: effect of endurance training. J Physiol. 1993 Sep;469:459-78. doi: 10.1113/jphysiol.1993.sp019823.
Results Reference
background
PubMed Identifier
12824093
Citation
Gregg EW, Gerzoff RB, Caspersen CJ, Williamson DF, Narayan KM. Relationship of walking to mortality among US adults with diabetes. Arch Intern Med. 2003 Jun 23;163(12):1440-7. doi: 10.1001/archinte.163.12.1440.
Results Reference
background
PubMed Identifier
1617788
Citation
Fletcher GF, Blair SN, Blumenthal J, Caspersen C, Chaitman B, Epstein S, Falls H, Froelicher ES, Froelicher VF, Pina IL. Statement on exercise. Benefits and recommendations for physical activity programs for all Americans. A statement for health professionals by the Committee on Exercise and Cardiac Rehabilitation of the Council on Clinical Cardiology, American Heart association. Circulation. 1992 Jul;86(1):340-4. doi: 10.1161/01.cir.86.1.340. No abstract available.
Results Reference
background
PubMed Identifier
8667571
Citation
Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
Results Reference
background
PubMed Identifier
9624661
Citation
American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.
Results Reference
background
PubMed Identifier
10912903
Citation
Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
Results Reference
background
PubMed Identifier
17762377
Citation
Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
Results Reference
background
PubMed Identifier
23180210
Citation
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.
Results Reference
result

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The Insulin Sensitivity Using Aerobic Interval Conditioning

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