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The 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
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Hypertension, Insulin Resistance, Hyperinsulinemia, Metformin, Fosinopril

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 26, 2011
    Last Updated
    May 11, 2011
    Sponsor
    China-Japan Friendship Hospital
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    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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