Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes - Full Text View

Purpose

Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus

Condition	Intervention
Diabetes Mellitus	Behavioral: Physical activity promoting intervention Behavioral: General instruction and education

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor)
Official Title:	Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Plasma adiponectin level in μg/ml [ Time Frame: Nine months after the start of the intervention ] [ Designated as safety issue: No ]
Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA).
Exercise behavior [ Time Frame: Nine months after the start of the intervention ] [ Designated as safety issue: No ]
1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

Secondary Outcome Measures:

Insulin resistance [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated
Metabolic components [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
1. Waist circumference (cm)
2. Fasting blood samples were centrifuged to obtain plasma for plasma triglycerides (TG) and high-density lipoprotein (HDL) levels in mg/dl
3. Plasma fasting glucose (FG) levels were measured in mg/dl by using the glucose oxidase membrane/hydrogen peroxide electrode method with the Antsense II analyzer (Bayer-Sankyo Co., Tokyo, Japan)
4. Systolic blood pressure (SBP) and dystolic blood pressure (DBP) in mmHg
Physical fitness [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
1. Body composition (kg/m^2): Body mass index that was weight in kilograms divided by the square of height in meter
2. Flexibility (cm): Meausred by sit-and-reach test
3. Grip strength (Nm): Measured by Jamar handheld dynameter
4. Muscle endurance (times/min): Measured by sit-up test
5. Cardiopulmonary fitness (3-minute step test)
Dietary intake [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
Measured by 24-hour recall guestionnaire in kcal/kg/day
Plasma adiponectin level in μg/ml [ Time Frame: Three and 6 months after the start of the intervention ] [ Designated as safety issue: No ]
Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA)
Exercise behavior [ Time Frame: Three and 6 months after the start of the intervention ] [ Designated as safety issue: No ]
1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

Enrollment:	216
Study Start Date:	January 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lifestyle counseling To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model	Behavioral: Physical activity promoting intervention An interview with a physiotherapist An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model The daily record to check their body weight, exercise mode and duration Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule Other Names: Home-based exercise Exercise behavior modification
Control Received oral instruction and written general education information without individualized exercise program	Behavioral: General instruction and education Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule Without individualized exercise program and interview with a physiotherapist Other Names: General advice Medical education

Arms

Assigned Interventions

Experimental: Lifestyle counseling

To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model

Behavioral: Physical activity promoting intervention

An interview with a physiotherapist
An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home
An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
The daily record to check their body weight, exercise mode and duration
Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details
Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule

Other Names:

Home-based exercise
Exercise behavior modification

Control

Received oral instruction and written general education information without individualized exercise program

Behavioral: General instruction and education

Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic
Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule
Without individualized exercise program and interview with a physiotherapist

Other Names:

General advice
Medical education

Detailed Description:

This randomized clinical trial was designed to investigate whether a home-based exercise could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin resistance, metabolic components and physical fitness) in subjects with at least a diabetic risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a control group or a home-based exercise group. All participants were evaluated for outcome measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the intervention.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

At least one of the following criteria as following: BMI >=24 kg/m*m, hypertension, dyslipidemia, fist-degree relatives of parents with type 2 diabetes, impaired glucose tolerance, gestational diabetes and delivering a babt weighing >=4.0 kg
Ability of understanding Chinese or Taiwanese

Exclusion Criteria:

Diabetes
Receiving treatment with insulin or oral hypoglycemic agents
Any other serious illness that prohibit them to undertake fitness evaluation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136096

Locations

Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

Study Director:

Ying-Tai Wu, Doctor

National Taiwan University Hospital

More Information

Publications:

Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44.

Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50.

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804.

Arita Y, Kihara S, Ouchi N, Takahashi M, Maeda K, Miyagawa J, Hotta K, Shimomura I, Nakamura T, Miyaoka K, Kuriyama H, Nishida M, Yamashita S, Okubo K, Matsubara K, Muraguchi M, Ohmoto Y, Funahashi T, Matsuzawa Y. Paradoxical decrease of an adipose-specific protein, adiponectin, in obesity. Biochem Biophys Res Commun. 1999 Apr 2;257(1):79-83.

Hotta K, Funahashi T, Arita Y, Takahashi M, Matsuda M, Okamoto Y, Iwahashi H, Kuriyama H, Ouchi N, Maeda K, Nishida M, Kihara S, Sakai N, Nakajima T, Hasegawa K, Muraguchi M, Ohmoto Y, Nakamura T, Yamashita S, Hanafusa T, Matsuzawa Y. Plasma concentrations of a novel, adipose-specific protein, adiponectin, in type 2 diabetic patients. Arterioscler Thromb Vasc Biol. 2000 Jun;20(6):1595-9.

Ouchi N, Kihara S, Arita Y, Maeda K, Kuriyama H, Okamoto Y, Hotta K, Nishida M, Takahashi M, Nakamura T, Yamashita S, Funahashi T, Matsuzawa Y. Novel modulator for endothelial adhesion molecules: adipocyte-derived plasma protein adiponectin. Circulation. 1999 Dec 21-28;100(25):2473-6.

King H, Kriska AM. Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. Diabetes Care. 1992 Nov;15(11):1794-9. Review.

Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2009 Jul 8;302(2):179-88. Review.

Responsible Party:	Ying-Tai Wu/, National Taiwan University
ClinicalTrials.gov Identifier:	NCT01136096 History of Changes
Other Study ID Numbers:	9261701067, DOH93-HP-1105, DOH94-HP-1105
Study First Received:	May 23, 2010
Last Updated:	June 2, 2010
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

diabetes
physical activity
adiponectin

metabolic risks
exercise
primary prevention

Additional relevant MeSH terms:

Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on May 16, 2013