The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension

Overview[ - collapse ][ - ]

Purpose The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.
ConditionDiabetes Mellitus
Essential Hypertension
InterventionDrug: Fosinopril
Drug: Metformin
PhaseN/A
SponsorChina-Japan Friendship Hospital
Responsible PartyChina-Japan Friendship Hospital
ClinicalTrials.gov IdentifierNCT01342614
First ReceivedApril 26, 2011
Last UpdatedMay 11, 2011
Last verifiedNovember 2005

Tracking Information[ + expand ][ + ]

First Received DateApril 26, 2011
Last Updated DateMay 11, 2011
Start DateMay 2006
Estimated Primary Completion DateAugust 2009
Current Primary Outcome MeasuresBlood pressure measurement [Time Frame: 8 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Official TitleThe Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Brief Summary
The objective of this study is to investigate the effect of metformin on the correlation
between hyperinsulinemia and hypertension.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes Mellitus
  • Essential Hypertension
InterventionDrug: Fosinopril
Fosinopril group received fosinopril, 10mg, once per day.
Drug: Metformin
Metformin group was treated with metformin hydrochloride, 500mg, three times per day
Study Arm (s)
  • Active Comparator: Fosinopril group
    Fosinopril group received fosinopril, 10mg, once per day.
  • Experimental: Metformin group
    Metformin group was treated with metformin hydrochloride, 500mg, three times per day

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment140
Estimated Completion DateAugust 2009
Estimated Primary Completion DateAugust 2009
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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01342614
Other Study ID NumbersMET140
Has Data Monitoring CommitteeYes
Information Provided ByChina-Japan Friendship Hospital
Study SponsorChina-Japan Friendship Hospital
CollaboratorsNot Provided
Investigators Not Provided
Verification DateNovember 2005