Diabetes MellitusNCT01342614
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
A study testing Fosinopril and Metformin in people with Diabetes Mellitus and Essential Hypertension, run by China-Japan Friendship Hospital.
Trial summary
The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Essential Hypertension
- What is being tested?
- Fosinopril and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 65 years of age, regardless of sex
- duration of hypertension was <5 years
- overweight or obesity, mild to moderate hypertension, receive no euglycemic agent or antiobesity drug
Who cannot join
None listed.
About this study
The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.
- Conditions
- Diabetes Mellitus, Essential Hypertension
- Being tested
- Fosinopril, Metformin
- Keywords
- Hypertension, Insulin Resistance, Hyperinsulinemia, Metformin, Fosinopril
- Medical subject headings
- Diabetes Mellitus, Essential Hypertension, Hypertension, Insulin Resistance, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosinoprilDrug
Fosinopril group received fosinopril, 10mg, once per day.
MetforminDrug
Metformin group was treated with metformin hydrochloride, 500mg, three times per day
| Study group | Role | What they receive |
|---|---|---|
| Fosinopril group | Active comparator | Fosinopril group received fosinopril, 10mg, once per day. Receives: Drug: Fosinopril |
| Metformin group | Experimental | Metformin group was treated with metformin hydrochloride, 500mg, three times per day Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startMay 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342614
- Sponsor's protocol ID
- MET140
- Status last verified
- Nov 2005
- First submitted
- 26 Apr 2011
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
- ClinicalTrials.gov ID
- NCT01342614
- Acronym / sponsor ID
- MET140
- Conditions
- Diabetes Mellitus, Essential Hypertension
- Keywords
- Hypertension, Insulin Resistance, Hyperinsulinemia, Metformin, Fosinopril
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Apr 2011 (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 of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosinopril group | Active comparator | Drug: FosinoprilFosinopril group received fosinopril, 10mg, once per day. |
| Metformin group | Experimental | Drug: MetforminMetformin group was treated with metformin hydrochloride, 500mg, three times per day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 65 years of age, regardless of sex
- duration of hypertension was <5 years
- overweight or obesity, mild to moderate hypertension, receive no euglycemic agent or antiobesity drug
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FosinoprilFosinopril group received fosinopril, 10mg, once per day. | Drug | Fosinopril group |
| MetforminMetformin group was treated with metformin hydrochloride, 500mg, three times per day | Drug | Metformin group |
Primary outcome
Blood pressure measurement
Time frame: 8 weeks
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 13 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fosinopril and Metformin in people with Diabetes Mellitus and Essential Hypertension, run by China-Japan Friendship 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 0 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 13 May 2011. 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. 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?
Blood pressure measurement (time frame: 8 weeks). 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 13 May 2011.