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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136096
• Other study ID #: 9261701067
• Secondary ID: DOH93-HP-1105DOH
• Status: Completed
• Phase: N/A
• First received: May 23, 2010
• Last updated: June 2, 2010
• Start date: January 2004
• Est. completion date: June 2005

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Insulin Resistance

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1001/jama.2009.976. Review. — View Citation

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. — View Citation

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. — View Citation

Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma adiponectin level in µg/ml	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).	Nine months after the start of the intervention	No
Primary	Exercise behavior	Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score; Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day	Nine months after the start of the intervention	No
Secondary	Insulin resistance	plasma inulin level (µU/ml) meausred by AxSYM with HOMA-IR was caculated	Three, 6 and 9 months after the start of the intervention	No
Secondary	Metabolic components	Waist circumference (cm); Fasting blood samples were centrifuged to obtain plasma for plasma triglycerides (TG) and high-density lipoprotein (HDL) levels in mg/dl; 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); Systolic blood pressure (SBP) and dystolic blood pressure (DBP) in mmHg	Three, 6 and 9 months after the start of the intervention	No
Secondary	Physical fitness	Body composition (kg/m^2): Body mass index that was weight in kilograms divided by the square of height in meter; Flexibility (cm): Meausred by sit-and-reach test; Grip strength (Nm): Measured by Jamar handheld dynameter; Muscle endurance (times/min): Measured by sit-up test; Cardiopulmonary fitness (3-minute step test)	Three, 6 and 9 months after the start of the intervention	No
Secondary	Dietary intake	Measured by 24-hour recall guestionnaire in kcal/kg/day	Three, 6 and 9 months after the start of the intervention	No
Secondary	Plasma adiponectin level in µg/ml	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)	Three and 6 months after the start of the intervention	No
Secondary	Exercise behavior	Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score; Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day	Three and 6 months after the start of the intervention	No