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Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes (HART-D)

This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), October 2008

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00458133
  Purpose

The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and men with type 2 diabetes (T2D).


Condition Intervention
Type 2 Diabetes
Behavioral: exercise

MedlinePlus related topics:   Diabetes    Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Basal insulin [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Resting blood pressure [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Visceral adiposity [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Cardiorespiratory fitness [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Muscular strength [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • metabolic measures, including serum cholesterol and triglycerides [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   360
Study Start Date:   April 2007
Estimated Study Completion Date:   June 2010
Estimated Primary Completion Date:   March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
We will randomly assign 100 individuals to an aerobic exercise training only group.
Behavioral: exercise
comparing effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
2: Experimental
We will randomly assign 100 individuals to an resistance exercise training only group.
Behavioral: exercise
comparing effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
3: Experimental
We will randomly assign 100 individuals to a combination of aerobic plus resistance training group.
Behavioral: exercise
comparing effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
4: Placebo Comparator
We will randomly assign 60 individuals to a stretching and relaxation group.
Behavioral: exercise
comparing effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.

Detailed Description:

Although it is generally accepted that regular exercise provides substantial health benefits to individuals with T2D, the exact exercise prescription in terms of type (AT versus RT versus AT+RT) still remains largely unexplored, particularly in regard to week-to-week glucose control as assessed by HbA1C.

There is a need for more adequately powered and well-controlled studies to examine the effects of RT, AT and AT+RT on HbA1C in individuals with T2D. With the incidence of T2D expected to increase dramatically in the coming years, it is essential to have a better understanding of the relative benefits of various exercise interventions. This information can help better formulate exercise recommendations for patients with T2D as well as potentially provide more exercise options, which is important given the small percentage of individuals with TD2 who regularly exercise.The study group will be sedentary women and men with T2D, aged 30 to 75 years. We will randomly assign 360 individuals to an aerobic exercise training only group (AT; n=100), a resistance training only group (RT; n=100), a combination of aerobic plus resistance training (AT+RT; n=100), or a standard care group (SC; n=60). The AT individuals will participate in 3 or 4 training sessions each week for 9 months progressing to a total energy expenditure of 12 kcal/kg/week (KKW), which is an exercise dose consistent with the current public health recommendations for physical activity for individuals with T2D. 1, 2 The target exercise intensity will be 50%-80% of baseline VO2 max. The RT group will participate in 3 sessions per week (9 exercises, 2-3 sets each), which focuses on large muscle groups. This RT regimen is based on the studies that most successfully improved HbA1C in individuals with T2D. Individuals in the AT+RT group will complete 10 KKW of aerobic training and a reduced resistance-training regimen of 2 sessions per week (9 exercises, 1 set of each). The AT+RT regimen represents the exercise recommendations of the American College of Sports Medicine (ACSM) and the American Diabetes Association (ADA).3, 4 All participants, including those in the SC group will complete a one hour consultation with a Certified Diabetes Educator (CDE) following randomization, during which, participants will be provided with educational materials and general guidelines for healthy living. Participants will also complete monthly sessions with the CDE, during which they will receive further instruction and guidance.

Simply stated, we wish to compare the effect of resistance training alone, resistance in combination with aerobic training, and aerobic training alone to standard care on HbA1C, in initially sedentary women and men with T2D. The primary outcome measure is HbA1C, an integrated measure of blood glucose control over the past 8-12 weeks. Other outcomes of interest include homeostasis model assessment (HOMA), resting blood pressure, C-reactive protein (CRP), visceral adiposity, total body fat, and lean muscle mass as measured by DEXA, cardiorespiratory fitness, muscular strength, and metabolic measures including serum cholesterol and triglycerides.

  Eligibility
Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age 30-75 years
  • type 2 diabetes determined by self-report with verification
  • 6.5% < HbA1C < 11%
  • sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise

Exclusion Criteria:

  • inadequate control of co-morbid conditions
  • resting blood pressure greater than or equal to 160/100 mm Hg
  • Triglycerides greater than or equal to 500 mg/dL
  • BMI > 43
  • current use of an insulin pump or insulin injections other than Lantus
  • metal object in the body that may interfere with MRI/MRS scans
  • factors that may limit adherence to intervention or affect conduct of the trial

    1. unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
    2. failure to complete behavioral run-in and baseline testing
    3. hospitalization for depression in the last 6 months
    4. not physically capable of performing the exercise required for the study protocols
    5. consuming > 14 alcoholic beverages per week
    6. plans to be away > 4 weeks in the next 9 months
    7. lack of support from primary health care provider or family members
    8. significant weight loss in the past year (>20 lbs) or current use of weight loss medications
    9. current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
    10. another member of household is a participant or staff member of HART-D
    11. bariatric surgery
    12. other temporary intervening event, such as sick spouse, bereavement, or recent move
    13. 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

    1. pregnant or plan on becoming pregnant in the next 9 months
    2. cancers requiring treatment in the past 5 years, unless prognosis is excellent
    3. self-reported HIV or tuberculosis
    4. history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
    5. renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dL (women) or is greater than or equal to 1.5 mg/dL (men) or currently receiving dialysis
    6. any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
    7. advanced neuropathy or retinopathy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458133

Contacts
Contact: Timothy S Church, MPH,MD, PhD     225-763-2632     Tim.Church@pbrc.edu    
Contact: Ruben Q Rodarte, MS     225-763-2919     Ruben.Rodarte@pbrc.edu    

Locations
United States, Louisiana
Pennington Biomedical Research Center     Recruiting
      Baton Rouge, Louisiana, United States, 70817
      Principal Investigator: Timothy S Church, MPH, MD, PhD            
      Sub-Investigator: Conrad P Earnest, PhD            
      Sub-Investigator: William T Cefalu, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Timothy S Church, MPH, MD, PhD     Pennington Biomedical Research Center    
  More Information


Publications:
Zinman B, Ruderman N, Campaigne BN, Devlin JT, Schneider SH; American Diabetes Association. Physical activity/exercise and diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S73-7. No abstract available.
 
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.
 
Hamdy O, Goodyear LJ, Horton ES. Diet and exercise in type 2 diabetes mellitus. Endocrinol Metab Clin North Am. 2001 Dec;30(4):883-907. Review.
 
Kelley DE, Goodpaster BH. Effects of exercise on glucose homeostasis in Type 2 diabetes mellitus. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S495-501; discussion S528-9. Review.
 
Nelson KM, Reiber G, Boyko EJ; NHANES III. Diet and exercise among adults with type 2 diabetes: findings from the third national health and nutrition examination survey (NHANES III). Diabetes Care. 2002 Oct;25(10):1722-8.
 
Khaw KT, Wareham N, Luben R, Bingham S, Oakes S, Welch A, Day N. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of european prospective investigation of cancer and nutrition (EPIC-Norfolk). BMJ. 2001 Jan 6;322(7277):15-8.
 
[No authors listed] Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602.
 
Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. Review.
 
Ishii T, Yamakita T, Sato T, Tanaka S, Fujii S. Resistance training improves insulin sensitivity in NIDDM subjects without altering maximal oxygen uptake. Diabetes Care. 1998 Aug;21(8):1353-5.
 
Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23.
 
Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41.
 
Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36.
 
Kumar S, Boulton AJ, Beck-Nielsen H, Berthezene F, Muggeo M, Persson B, Spinas GA, Donoghue S, Lettis S, Stewart-Long P. Troglitazone, an insulin action enhancer, improves metabolic control in NIDDM patients. Troglitazone Study Group. Diabetologia. 1996 Jun;39(6):701-9. Erratum in: Diabetologia 1996 Oct;39(10):1245.
 
Hanley AJ, Williams K, Stern MP, Haffner SM. Homeostasis model assessment of insulin resistance in relation to the incidence of cardiovascular disease: the San Antonio Heart Study. Diabetes Care. 2002 Jul;25(7):1177-84.
 
Katsuki A, Sumida Y, Gabazza EC, Murashima S, Furuta M, Araki-Sasaki R, Hori Y, Yano Y, Adachi Y. Homeostasis model assessment is a reliable indicator of insulin resistance during follow-up of patients with type 2 diabetes. Diabetes Care. 2001 Feb;24(2):362-5.
 
Dumortier M, Brandou F, Perez-Martin A, Fedou C, Mercier J, Brun JF. Low intensity endurance exercise targeted for lipid oxidation improves body composition and insulin sensitivity in patients with the metabolic syndrome. Diabetes Metab. 2003 Nov;29(5):509-18.
 
Helge JW. Prolonged adaptation to fat-rich diet and training; effects on body fat stores and insulin resistance in man. Int J Obes Relat Metab Disord. 2002 Aug;26(8):1118-24.
 
Miyatake N, Takahashi K, Wada J, Nishikawa H, Morishita A, Suzuki H, Kunitomi M, Makino H, Kira S, Fujii M. Daily exercise lowers blood pressure and reduces visceral adipose tissue areas in overweight Japanese men. Diabetes Res Clin Pract. 2003 Dec;62(3):149-57.
 
Stewart KJ. Exercise training and the cardiovascular consequences of type 2 diabetes and hypertension: plausible mechanisms for improving cardiovascular health. JAMA. 2002 Oct 2;288(13):1622-31. Review.
 
Grossman E, Messerli FH, Goldbourt U. High blood pressure and diabetes mellitus: are all antihypertensive drugs created equal? Arch Intern Med. 2000 Sep 11;160(16):2447-52. Review.
 
Kelley GA, Kelley KA, Tran ZV. Aerobic exercise and resting blood pressure: a meta-analytic review of randomized, controlled trials. Prev Cardiol. 2001 Spring;4(2):73-80.
 
Leon AS, Sanchez OA. Response of blood lipids to exercise training alone or combined with dietary intervention. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S502-15; discussion S528-9. Review.
 
Taylor PA, Ward A. Women, high-density lipoprotein cholesterol, and exercise. Arch Intern Med. 1993 May 24;153(10):1178-84. Review.
 
Durstine JL, Haskell WL. Effects of exercise training on plasma lipids and lipoproteins. Exerc Sport Sci Rev. 1994;22:477-521. Review. No abstract available.
 
Maiorana A, O'Driscoll G, Goodman C, Taylor R, Green D. Combined aerobic and resistance exercise improves glycemic control and fitness in type 2 diabetes. Diabetes Res Clin Pract. 2002 May;56(2):115-23.
 
Dunstan DW, Puddey IB, Beilin LJ, Burke V, Morton AR, Stanton KG. Effects of a short-term circuit weight training program on glycaemic control in NIDDM. Diabetes Res Clin Pract. 1998 Apr;40(1):53-61.
 
Eriksson J, Taimela S, Eriksson K, Parviainen S, Peltonen J, Kujala U. Resistance training in the treatment of non-insulin-dependent diabetes mellitus. Int J Sports Med. 1997 May;18(4):242-6.
 
Honkola A, Forsen T, Eriksson J. Resistance training improves the metabolic profile in individuals with type 2 diabetes. Acta Diabetol. 1997 Dec;34(4):245-8.
 
Haffner SM. Insulin resistance, inflammation, and the prediabetic state. Am J Cardiol. 2003 Aug 18;92(4A):18J-26J. Review.
 
Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43.
 
Ridker PM. High-sensitivity C-reactive protein: potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation. 2001 Apr 3;103(13):1813-8.
 
Church TS, Barlow CE, Earnest CP, Kampert JB, Priest EL, Blair SN. Associations between cardiorespiratory fitness and C-reactive protein in men. Arterioscler Thromb Vasc Biol. 2002 Nov 1;22(11):1869-76.
 
Nguyen-Duy TB, Nichaman MZ, Church TS, Blair SN, Ross R. Visceral fat and liver fat are independent predictors of metabolic risk factors in men. Am J Physiol Endocrinol Metab. 2003 Jun;284(6):E1065-71. Epub 2003 Jan 28.
 
Mourier A, Gautier JF, De Kerviler E, Bigard AX, Villette JM, Garnier JP, Duvallet A, Guezennec CY, Cathelineau G. Mobilization of visceral adipose tissue related to the improvement in insulin sensitivity in response to physical training in NIDDM. Effects of branched-chain amino acid supplements. Diabetes Care. 1997 Mar;20(3):385-91.
 
Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. Review.
 
Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41.
 
Kohl HW 3rd, Dunn AL, Marcus BH, Blair SN. A randomized trial of physical activity interventions: design and baseline data from project active. Med Sci Sports Exerc. 1998 Feb;30(2):275-83.
 
Blair SN, Applegate WB, Dunn AL, Ettinger WH, Haskell WL, King AC, Morgan TM, Shih JA, Simons-Morton DG. Activity Counseling Trial (ACT): rationale, design, and methods. Activity Counseling Trial Research Group. Med Sci Sports Exerc. 1998 Jul;30(7):1097-106.
 
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9.
 
Smutok MA, Reece C, Kokkinos PF, Farmer C, Dawson P, Shulman R, DeVane-Bell J, Patterson J, Charabogos C, Goldberg AP, et al. Aerobic versus strength training for risk factor intervention in middle-aged men at high risk for coronary heart disease. Metabolism. 1993 Feb;42(2):177-84.
 
Smutok MA, Reece C, Kokkinos PF, Farmer CM, Dawson PK, DeVane J, Patterson J, Goldberg AP, Hurley BF. Effects of exercise training modality on glucose tolerance in men with abnormal glucose regulation. Int J Sports Med. 1994 Aug;15(6):283-9.
 
[No authors listed] Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6. Review.
 
[No authors listed] Surgeon General's report on physical activity and health. From the Centers for Disease Control and Prevention. JAMA. 1996 Aug 21;276(7):522. No abstract available.
 
Snyder KA, Donnelly JE, Jabobsen DJ, Hertner G, Jakicic JM. The effects of long-term, moderate intensity, intermittent exercise on aerobic capacity, body composition, blood lipids, insulin and glucose in overweight females. Int J Obes Relat Metab Disord. 1997 Dec;21(12):1180-9.
 
Willey KA, Singh MA. Battling insulin resistance in elderly obese people with type 2 diabetes: bring on the heavy weights. Diabetes Care. 2003 May;26(5):1580-8. Review.
 

Responsible Party:   Pennington Biomedical Research Center ( Timothy S. Church, MD, MPH, PhD, Principal Investigator )
Study ID Numbers:   DK68298
First Received:   April 5, 2007
Last Updated:   October 7, 2008
ClinicalTrials.gov Identifier:   NCT00458133
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
aerobic exercise  
resistance exercise  
type 2 diabetes  
hemoglobin A1C  
exercise  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2008




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