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

NCT ID: NCT01136096

Last Updated: 2010-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lifestyle counseling

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

Group Type EXPERIMENTAL

Physical activity promoting intervention

Intervention Type BEHAVIORAL

1. An interview with a physiotherapist
2. 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
3. An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
4. The daily record to check their body weight, exercise mode and duration
5. 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
6. 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

Control

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

Group Type OTHER

General instruction and education

Intervention Type BEHAVIORAL

1. 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
2. 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
3. Without individualized exercise program and interview with a physiotherapist

Interventions

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Physical activity promoting intervention

1. An interview with a physiotherapist
2. 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
3. An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
4. The daily record to check their body weight, exercise mode and duration
5. 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
6. 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

Intervention Type BEHAVIORAL

General instruction and education

1. 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
2. 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
3. Without individualized exercise program and interview with a physiotherapist

Intervention Type BEHAVIORAL

Other Intervention Names

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Home-based exercise Exercise behavior modification General advice Medical education

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University

Principal Investigators

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Ying-Tai Wu, Doctor

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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. doi: 10.2337/diacare.20.4.537.

Reference Type BACKGROUND
PMID: 9096977 (View on PubMed)

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. doi: 10.1056/NEJM200105033441801.

Reference Type BACKGROUND
PMID: 11333990 (View on PubMed)

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. doi: 10.1056/NEJMoa012512.

Reference Type BACKGROUND
PMID: 11832527 (View on PubMed)

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. doi: 10.1001/jama.289.14.1799.

Reference Type BACKGROUND
PMID: 12684358 (View on PubMed)

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. doi: 10.1006/bbrc.1999.0255.

Reference Type BACKGROUND
PMID: 10092513 (View on PubMed)

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. doi: 10.1161/01.atv.20.6.1595.

Reference Type BACKGROUND
PMID: 10845877 (View on PubMed)

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. doi: 10.1161/01.cir.100.25.2473.

Reference Type BACKGROUND
PMID: 10604883 (View on PubMed)

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. doi: 10.2337/diacare.15.11.1794.

Reference Type BACKGROUND
PMID: 1468317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19584347 (View on PubMed)

Chen CN, Chuang LM, Korivi M, Wu YT. Home-based exercise may not decrease the insulin resistance in individuals with metabolic syndrome. J Phys Act Health. 2015 Jan;12(1):74-9. doi: 10.1123/jpah.2013-0284. Epub 2014 Feb 5.

Reference Type DERIVED
PMID: 24509907 (View on PubMed)

Other Identifiers

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DOH93-HP-1105

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DOH94-HP-1105

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

9261701067

Identifier Type: -

Identifier Source: org_study_id

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