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Diabetes MellitusNCT01136096

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

A study testing Physical activity promoting intervention and General instruction and education in people with Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Physical activity promoting intervention and General instruction and education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteTaiwan
Study dates
Jan 2004to Jun 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

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

Read the 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.

Being tested
Physical activity promoting intervention, General instruction and education
Keywords
diabetes, physical activity, adiponectin, metabolic risks, exercise, primary prevention
Medical subject headings
Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity promoting interventionBehavioural

    Also called Home-based exercise, Exercise behavior modification

    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

  • General instruction and educationBehavioural

    Also called General advice, Medical 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
Study groups in NCT01136096
Study groupRoleWhat they receive
Lifestyle counselingExperimentalTo promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model
Receives: Behavioral: Physical activity promoting intervention
ControlOtherReceived oral instruction and written general education information without individualized exercise program
Receives: Behavioral: General instruction and education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Nine months after the start of the intervention

  2. Exercise behavior

    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

    Measured: Nine months after the start of the intervention

Secondary outcomes (6)

  1. Insulin resistance

    plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated

    Measured: Three, 6 and 9 months after the start of the intervention

  2. Metabolic components

    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

    Measured: Three, 6 and 9 months after the start of the intervention

  3. Physical fitness

    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)

    Measured: Three, 6 and 9 months after the start of the intervention

  4. Dietary intake

    Measured by 24-hour recall guestionnaire in kcal/kg/day

    Measured: Three, 6 and 9 months after the start of the intervention

  5. 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)

    Measured: Three and 6 months after the start of the intervention

  6. Exercise behavior

    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

    Measured: Three and 6 months after the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2010 (estimated)
  2. Study startJan 2004
  3. Primary completionJun 2005
  4. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01136096
Sponsor's protocol ID
9261701067
Other IDs
DOH93-HP-1105, DOH94-HP-1105
Status last verified
Jun 2010
First submitted
23 May 2010
Last updated
3 Jun 2010
Results posted
No
Data monitoring committee
Yes

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. doi: 10.2337/diacare.20.4.537.

    PubMed 9096977

  • 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.

    PubMed 11333990

  • 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.

    PubMed 11832527

  • 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.

    PubMed 12684358

  • 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.

    PubMed 10092513

  • 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.

    PubMed 10845877

  • 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.

    PubMed 10604883

  • 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.

    PubMed 1468317

  • 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.

    PubMed 19584347

  • 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.

    PubMed 24509907

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity promoting intervention and General instruction and education in people with Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma adiponectin level in μg/ml (time frame: Nine months after the start of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01136096, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.

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