Back to resultsThe Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Primary Purpose
Diabetes Mellitus, Essential Hypertension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fosinopril
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Hypertension, Insulin Resistance, Hyperinsulinemia, Metformin, Fosinopril
Eligibility Criteria
Inclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fosinopril group
Metformin group
Arm Description
Fosinopril group received fosinopril, 10mg, once per day.
Metformin group was treated with metformin hydrochloride, 500mg, three times per day
Outcomes
Primary Outcome Measures
Blood pressure measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT01342614
First Posted
April 26, 2011
Last Updated
May 11, 2011
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01342614
Brief Title
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Official Title
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Essential Hypertension
Keywords
Hypertension, Insulin Resistance, Hyperinsulinemia, Metformin, Fosinopril
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fosinopril group
Arm Type
Active Comparator
Arm Description
Fosinopril group received fosinopril, 10mg, once per day.
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
Metformin group was treated with metformin hydrochloride, 500mg, three times per day
Intervention Type
Drug
Intervention Name(s)
Fosinopril
Intervention Description
Fosinopril group received fosinopril, 10mg, once per day.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin group was treated with metformin hydrochloride, 500mg, three times per day
Primary Outcome Measure Information:
Title
Blood pressure measurement
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
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