Cardiovascular DiseasesNCT00889876
Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for CVD Among Obese Adolescents
A study testing Metformin group and Exercise in people with Cardiovascular Diseases, run by Maria Sandberg Westerstahl at 1 site in Sweden.
Trial summary
The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Metformin group and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to Dec 2015
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-19 years old at inclusion date
- Obesity according to gender and age specific BMI (Cole 2000)
- Reduced nocturnal systolic blood pressure fall (< 10%)
- Signed informed consent by patient and parents
Who cannot join
- Cardiovascular disease
- Insulin dependent diabetes mellitus
- Patient on medications that are contraindicated during Metformin treatment
- Pregnancy
- Mental or physical conditions limiting the ability to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Karolinska University Hospital Huddinge
Stockholm, 141 86
About this study
Official title: Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents
The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.
Read the detailed description
Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.
- Conditions
- Cardiovascular Diseases
- Being tested
- Metformin group, Exercise
- Keywords
- Obesity, Adolescents, Nocturnal blood pressure reduction, Insulin metabolism, Cardiovascular structure and function, Treatment, Exercise, Metformin, Insulin, Blood glucose, Impaired nocturnal blood pressure reduction
- Medical subject headings
- Cardiovascular Diseases, Obesity, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin groupDrug
2000 mg/day for one year
ExerciseBehavioural
3 times/week with a personal coach for one year. Endurance training.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin group |
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of nocturnal blood pressure dipping
Measured: Before and 3, 6 and 12 months of intervention
Secondary outcomes (1)
Normalization of insulin metabolism and cardiovascular structure and function
Measured: Before and 3, 6 and 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: hard to recruite, no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sandberg Westerstahl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Sandberg Westerstahl, Karolinska Institutet
- Investigators
- Claude Marcus, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889876
- Sponsor's protocol ID
- 2008-000461-28
- Other IDs
- 2008
- Status last verified
- Feb 2011
- First submitted
- 27 Apr 2009
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents
- ClinicalTrials.gov ID
- NCT00889876
- Acronym / sponsor ID
- 2008-000461-28
- Conditions
- Cardiovascular Diseases
- Keywords
- Obesity, Adolescents, Nocturnal blood pressure reduction, Insulin metabolism, Cardiovascular structure and function, Treatment, Exercise, Metformin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: hard to recruite, no funding
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Maria Sandberg WesterstahlUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 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 objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.
Detailed description
Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin group |
| Exercise | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-19 years old at inclusion date
- Obesity according to gender and age specific BMI (Cole 2000)
- Reduced nocturnal systolic blood pressure fall (< 10%)
- Signed informed consent by patient and parents
Key exclusion criteria (5 listed)
- Cardiovascular disease
- Insulin dependent diabetes mellitus
- Patient on medications that are contraindicated during Metformin treatment
- Pregnancy
- Mental or physical conditions limiting the ability to participate
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 group2000 mg/day for one year | Drug | Metformin |
| Exercise3 times/week with a personal coach for one year. Endurance training. | Behavioural | Exercise |
Primary outcome
Normalization of nocturnal blood pressure dipping
Time frame: Before and 3, 6 and 12 months of intervention
1 secondary outcome
Normalization of insulin metabolism and cardiovascular structure and function
Time frame: Before and 3, 6 and 12 months of intervention
Results and safety
The study was stopped early (reason given: hard to recruite, no funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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.
Claude Marcus, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin group and Exercise in people with Cardiovascular Diseases, run by Maria Sandberg Westerstahl at 1 site in Sweden.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Apr 2023. 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 Sweden. 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 was stopped early (reason given: hard to recruite, no funding). Results are not available in the source record.
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?
Normalization of nocturnal blood pressure dipping (time frame: Before and 3, 6 and 12 months of intervention). 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 4 Apr 2023.