NCT01342614

Brief Summary

The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
Last Updated

May 13, 2011

Status Verified

November 1, 2005

Enrollment Period

3.3 years

First QC Date

April 26, 2011

Last Update Submit

May 11, 2011

Conditions

Diabetes MellitusEssential Hypertension

Keywords

HypertensionInsulin ResistanceHyperinsulinemiaMetforminFosinopril

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measurement

    8 weeks

Study Arms (2)

Fosinopril group

ACTIVE COMPARATOR

Fosinopril group received fosinopril, 10mg, once per day.

Drug: Fosinopril

Metformin group

EXPERIMENTAL

Metformin group was treated with metformin hydrochloride, 500mg, three times per day

Drug: Metformin

Interventions

FosinoprilDRUG

Fosinopril group received fosinopril, 10mg, once per day.

Fosinopril group
MetforminDRUG

Metformin group was treated with metformin hydrochloride, 500mg, three times per day

Metformin group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusEssential HypertensionHypertensionInsulin ResistanceHyperinsulinism

Interventions

FosinoprilMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phosphinic AcidsOrganophosphorus CompoundsOrganic ChemicalsProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

May 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 13, 2011

Record last verified: 2005-11