NCT00402194

Brief Summary

A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity in skeletal muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

June 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 24, 2013

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

6.4 years

First QC Date

November 20, 2006

Results QC Date

May 6, 2013

Last Update Submit

September 20, 2013

Conditions

ObesityInsulin ResistanceImpaired Glucose TolerancePre-diabetes

Keywords

ObesityInsulin resistanceImpaired glucose tolerancepre-diabetes

Outcome Measures

Primary Outcomes (2)

  • Leg Blood Flow Response to Insulin

    3 months

  • Insulin-stimulated Leg Glucose Uptake

    3 months

Interventions

LosartanDRUG

Tablet, 100mg, once per day for 3 months

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Age 20-55
  • Male and female
  • Obese, defined as Males: BMI \>28 or \> 30% fat by DEXA scan or Bod Pod; Females: BMI \>30 or \> 33% fat by DEXA scan or Bod Pod
  • Weight stable over at least 4 months

You may not qualify if:

  • Diabetes mellitus (ADA criteria)
  • Age \<20 or \> 55 yrs
  • Blood pressure \>160/90 or \< 90/65 mmHg
  • Total cholesterol \>240 or LDL cholesterol \>160 mg/dL
  • Baseline elevations in AST or ALT \> 3X ULN
  • Baseline elevation in creatinine \>1.6 ng/mL
  • Unexplained baseline elevation in creatine kinase \> 3X ULN
  • Concurrent significant chronic medical illness including, but not limited to, human immunodeficiency virus infection, Syphilis, hepatitis B infection, or hepatitis C infection
  • Pregnancy
  • Known hypersensitivity or intolerance to the study agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital GCRC

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceGlucose Intolerance

Interventions

Losartan

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Results Point of Contact

Title
Dr. Kieren Mather
Organization
Indiana University
kmather@iu.edu
317-278-7826

Study Officials

  • Kieren J Mather, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

June 1, 2005

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

September 24, 2013

Results First Posted

September 24, 2013

Record last verified: 2013-09

Locations

US(1)