Body WeightPhase 4NCT00134290
The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
A Phase 4 study testing metformin, "standard diet advice" and "personal diet advice" in people with Body Weight and Insulin Resistance, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a study to: Determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and Determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Body Weight, Insulin Resistance
- What is being tested?
- metformin, "standard diet advice" and "personal diet advice"
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2002to May 2004
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-55 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m²
- Insulin resistance as determined by oral glucose tolerance test (OGTT) and HOMA
Who cannot join
- Diabetes mellitus, kidney insufficiency, or hepatic insufficiency
- Hypogonadism with other etiology than overweight
- Pregnancy
- BMI equal to or greater than 40 kg/m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Calorie Restriction - Whether or Not Calculated Based on BMR (Basic Metabolic Rate) - With or Without Metformin on Weight and Insulin Resistance of Obese Insulin Resistant Patients
This is a study to:
- Determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and
- Determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo.
Read the detailed description
The aim of the present study was to determine what the difference is of a strong hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice" which was determined by the energy needs of a person as calculated with a combination of basal metabolic rate (BMR) and physical activity level (PAL) on weight loss and insulin sensitivity.
Secondly, this study wanted to determine what the influence is of insulin-insensitivity on obesity and weight reduction by treating the patients with metformin or placebo. The subjects were therefore randomised into two double blinded groups receiving either metformin (2 x 850 mg per day) or placebo in combination with a moderate energy restriction and a exercise regimen of 30 minutes per day for 1 year.
Treatment effects of both diets and the effect of metformin on weight reduction and insulin sensitivity were determined after a treatment period of 20 and 52 weeks.
Insulin sensitivity was quantified using the homeostasis model assessment (HOMA) and the OGTT. Body composition was determined with the bioelectrical impedance method.
Blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of treatment. Furthermore, the patients had to fill out a 3-day food diary at baseline, after 20 weeks and after 52 weeks.
- Conditions
- Body Weight, Insulin Resistance
- Being tested
- metformin, "standard diet advice", "personal diet advice"
- Medical subject headings
- Body Weight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
"standard diet advice"Behavioural
"personal diet advice"Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
Secondary outcomes (1)
Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startJan 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Mimi Giri, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134290
- Sponsor's protocol ID
- 2002/032
- Status last verified
- Dec 2007
- First submitted
- 23 Aug 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Calorie Restriction - Whether or Not Calculated Based on BMR (Basic Metabolic Rate) - With or Without Metformin on Weight and Insulin Resistance of Obese Insulin Resistant Patients
- ClinicalTrials.gov ID
- NCT00134290
- Acronym / sponsor ID
- 2002/032
- Conditions
- Body Weight, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- May 2004 (actual)
- First posted
- 24 Aug 2005 (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.
This is a study to:
- Determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and
- Determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo.
Detailed description
The aim of the present study was to determine what the difference is of a strong hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice" which was determined by the energy needs of a person as calculated with a combination of basal metabolic rate (BMR) and physical activity level (PAL) on weight loss and insulin sensitivity.
Secondly, this study wanted to determine what the influence is of insulin-insensitivity on obesity and weight reduction by treating the patients with metformin or placebo. The subjects were therefore randomised into two double blinded groups receiving either metformin (2 x 850 mg per day) or placebo in combination with a moderate energy restriction and a exercise regimen of 30 minutes per day for 1 year.
Treatment effects of both diets and the effect of metformin on weight reduction and insulin sensitivity were determined after a treatment period of 20 and 52 weeks.
Insulin sensitivity was quantified using the homeostasis model assessment (HOMA) and the OGTT. Body composition was determined with the bioelectrical impedance method.
Blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of treatment. Furthermore, the patients had to fill out a 3-day food diary at baseline, after 20 weeks and after 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-55 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m²
- Insulin resistance as determined by oral glucose tolerance test (OGTT) and HOMA
Key exclusion criteria (4 listed)
- Diabetes mellitus, kidney insufficiency, or hepatic insufficiency
- Hypogonadism with other etiology than overweight
- Pregnancy
- BMI equal to or greater than 40 kg/m²
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 |
|---|---|---|
| metformin | Drug | – |
| "standard diet advice" | Behavioural | – |
| "personal diet advice" | Behavioural | – |
Primary outcome
Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
1 secondary outcome
Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
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 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Mimi Giri, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metformin, "standard diet advice" and "personal diet advice" in people with Body Weight and Insulin Resistance, run by University Hospital, Ghent at 1 site in Belgium.
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 4 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 28 Dec 2007. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment. It is what the study was designed to measure, not a finding.
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 28 Dec 2007.