ObesityPhase 4REACHNCT00934570
Activity and Metformin Intervention in Obese Adolescents
A Phase 4 study testing Metformin and standard exercise, Metformin Intensive exercise and Intensive exercise in people with Obesity and Type 2 Diabetes, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Metformin and standard exercise, Metformin Intensive exercise and Intensive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to May 2012
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Obese adolescents defined as BMI greater than the 95th percentile for age and gender
- Metformin naive subjects
Who cannot join
- Elevated fasting plasma glucose ≥ 6.0 mmol/L
- 2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
- A1C > 6.0%
- Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
- Smoking
- Pregnancy
Show all 21Show fewer
- Renal insufficiency (serum creatinine > the upper limit of normal)
- Hepatic dysfunction (> 1.5 times the upper limit of normal for AST and ALT)
- Latex Allergy
- Hypersensitivity to metformin or its ingredients
- Breast feeding
- Subjects with a history of lactic acidosis
- Abnormal creatinine clearance
- HIV, HBV, and HCV infections
- Drug and alcohol abuse
- Severe mental disorders
- Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials
- Participation in another clinical trial
- Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders
- Malignant diseases
- Previous exposure to any pharmaceutical antidiabetic agent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
Official title: Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.
Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.
Read the detailed description
This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Metformin and standard exercise, Metformin Intensive exercise, Placebo Standard exercise, Intensive exercise
- Keywords
- Obesity, Metformin, Physical activity, Cardiovascular health
- Medical subject headings
- Obesity, 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.
Metformin and standard exerciseDrug
Also called GlumetzaTM 500 mg Extended Release
Metformin 1500 mg daily for 2 years
Metformin Intensive exerciseDrug
Also called GlumetzaTM 500 mg Extended Release
Metformin 1500 mg daily for 2 years
Placebo Standard exerciseBehavioural
Standard exercise
Intensive exerciseBehavioural
Placebo Intensive exercise
| Study group | Role | What they receive |
|---|---|---|
| Metformin, Standard exercise | Active comparator | Lifestyle intervention with metformin and standard exercise program. Receives: Drug: Metformin and standard exercise |
| Placebo, Standard exercise | Placebo comparator | Lifestyle intervention with placebo and standard exercise program Receives: Behavioral: Placebo Standard exercise |
| Metformin, Intensive exercise | Active comparator | Lifestyle intervention with metformin and intensive exercise Receives: Drug: Metformin Intensive exercise |
| Placebo, Intensive exercise | Placebo comparator | Lifestyle intervention with placebo and intensive exercise program. Receives: Behavioral: Intensive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in BMI
Measured: 2 years
Secondary outcomes (1)
Improvement in physical activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Cheryl, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Cheril Clarson, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934570
- Sponsor's protocol ID
- R-08-259
- Other IDs
- 15590
- Acronym
- REACH
- Status last verified
- Oct 2012
- First submitted
- 6 Jul 2009
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Clarson CL, Brown HK, De Jesus S, Jackman M, Mahmud FH, Prapavessis H, Robinson T, Shoemaker JK, Watson M, Dowd AJ, Hill DJ. Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents. Int Sch Res Notices. 2014 Nov 10;2014:659410. doi: 10.1155/2014/659410. eCollection 2014.
PubMed 27433488Wilson AJ, Prapavessis H, Jung ME, Cramp AG, Vascotto J, Lenhardt L, Shoemaker JK, Watson M, Robinson T, Clarson CL. Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol. BMC Public Health. 2009 Nov 30;9:434. doi: 10.1186/1471-2458-9-434.
PubMed 19943971
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00934570
- Acronym / sponsor ID
- REACH / R-08-259
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Metformin, Physical activity, Cardiovascular health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jul 2009 (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 is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.
Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.
Detailed description
This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin, Standard exercise | Active comparator | Drug: Metformin and standard exerciseLifestyle intervention with metformin and standard exercise program. |
| Placebo, Standard exercise | Placebo comparator | Behavioral: Placebo Standard exerciseLifestyle intervention with placebo and standard exercise program |
| Metformin, Intensive exercise | Active comparator | Drug: Metformin Intensive exerciseLifestyle intervention with metformin and intensive exercise |
| Placebo, Intensive exercise | Placebo comparator | Behavioral: Intensive exerciseLifestyle intervention with placebo and intensive exercise program. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Obese adolescents defined as BMI greater than the 95th percentile for age and gender
- Metformin naive subjects
Key exclusion criteria (21 listed)
- Elevated fasting plasma glucose ≥ 6.0 mmol/L
- 2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
- A1C > 6.0%
- Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
- Smoking
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 and standard exerciseAlso: GlumetzaTM 500 mg Extended ReleaseMetformin 1500 mg daily for 2 years | Drug | Metformin, Standard exercise |
| Metformin Intensive exerciseAlso: GlumetzaTM 500 mg Extended ReleaseMetformin 1500 mg daily for 2 years | Drug | Metformin, Intensive exercise |
| Placebo Standard exerciseStandard exercise | Behavioural | Placebo, Standard exercise |
| Intensive exercisePlacebo Intensive exercise | Behavioural | Placebo, Intensive exercise |
Primary outcome
Reduction in BMI
Time frame: 2 years
1 secondary outcome
Improvement in physical activity
Time frame: 2 years
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 4 Oct 2012.
- Derived from this study: PubMed 27433488Clarson CL, Brown HK, De Jesus S, Jackman M, Mahmud FH, Prapavessis H, Robinson T, Shoemaker JK, Watson M, Dowd AJ, Hill DJ. Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents. Int Sch Res Notices. 2014 Nov 10;2014:659410. doi: 10.1155/2014/659410. eCollection 2014.
- Derived from this study: PubMed 19943971Wilson AJ, Prapavessis H, Jung ME, Cramp AG, Vascotto J, Lenhardt L, Shoemaker JK, Watson M, Robinson T, Clarson CL. Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol. BMC Public Health. 2009 Nov 30;9:434. doi: 10.1186/1471-2458-9-434.
- Click here for more information about this study: Metformin and Activity Intervention in Obese AdolescentsLink 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.
Cheril Clarson, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 and standard exercise, Metformin Intensive exercise and Intensive exercise in people with Obesity and Type 2 Diabetes, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 21 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 4 Oct 2012. 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 Canada. 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. 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.
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?
Reduction in BMI (time frame: 2 years). 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 NCT00934570, which also lists 2 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 4 Oct 2012.