Insulin SensitivityNCT00763074
Exercise and Diet in Type 2 Diabetic Women
A study testing Standard life style modification for type 2 diabetes, Diet restriction and Exercise in people with Insulin Sensitivity and Type 2 Diabetes, run by Eulji University Hospital.
Trial summary
The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Insulin Sensitivity, Type 2 Diabetes
- What is being tested?
- Standard life style modification for type 2 diabetes, Diet restriction and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Mar 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetic patient
- BMI>23kg/m2
- Female
Who cannot join
- The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis
About this study
Official title: Clinical Trial of Exercise and Diet in Type 2 Diabetic Women
The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Being tested
- Standard life style modification for type 2 diabetes, Diet restriction, Exercise, Diet and exercise
- Keywords
- Intra-Abdominal Fat, Adipokines, Exercise, Diet therapy
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard life style modification for type 2 diabetesBehavioural
Two session of education for exercise and diet.
----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30~35kcal/day
Diet restrictionBehavioural
Education for diet and exercise every 2 weeks
----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day
ExerciseBehavioural
Education for diet and exercise every 2 weeks
----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day
Diet and exerciseBehavioural
Education for diet and exercise every 2 weeks
----------- Exercise education like as exercise group and diet education like as diet group
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Conventional education of life style intervention for type 2 diabetes Receives: Behavioral: Standard life style modification for type 2 diabetes |
| Diet | Active comparator | Dietary calorie restriction Receives: Behavioral: Diet restriction |
| Exercise | Active comparator | Encourage to increase exercise amount: more than 60min's of exercise with moderate activity level two times per day Receives: Behavioral: Exercise |
| Diet and exercise | Active comparator | Intervention for both of exercise and diet Receives: Behavioral: Diet and exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startApr 2006
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung Wan Min, Professor, Principal investigator, Eulji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763074
- Sponsor's protocol ID
- Obesity_2006_1
- Status last verified
- Sep 2008
- First submitted
- 29 Sep 2008
- Last updated
- 12 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Exercise and Diet in Type 2 Diabetic Women
- ClinicalTrials.gov ID
- NCT00763074
- Acronym / sponsor ID
- Obesity_2006_1
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Keywords
- Intra-Abdominal Fat, Adipokines, Exercise, Diet therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Standard life style modification for type 2 diabetesConventional education of life style intervention for type 2 diabetes |
| Diet | Active comparator | Behavioral: Diet restrictionDietary calorie restriction |
| Exercise | Active comparator | Behavioral: ExerciseEncourage to increase exercise amount: more than 60min's of exercise with moderate activity level two times per day |
| Diet and exercise | Active comparator | Behavioral: Diet and exerciseIntervention for both of exercise and diet |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetic patient
- BMI>23kg/m2
- Female
Key exclusion criteria (1 listed)
- The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard life style modification for type 2 diabetesTwo session of education for exercise and diet. ----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30~35kcal/day | Behavioural | Control |
| Diet restrictionEducation for diet and exercise every 2 weeks ----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day | Behavioural | Diet |
| ExerciseEducation for diet and exercise every 2 weeks ----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day | Behavioural | Exercise |
| Diet and exerciseEducation for diet and exercise every 2 weeks ----------- Exercise education like as exercise group and diet education like as diet group | Behavioural | Diet and exercise |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2008.
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Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Wan Min, Professor principal investigator
Eulji University
Questions about this trial
What is this clinical trial studying?
A study testing Standard life style modification for type 2 diabetes, Diet restriction and Exercise in people with Insulin Sensitivity and Type 2 Diabetes, run by Eulji University Hospital.
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 3 inclusion and 1 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 12 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
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 12 Dec 2008.