NCT01406015

Brief Summary

The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4.5 years

First QC Date

July 26, 2011

Results QC Date

January 29, 2017

Last Update Submit

March 20, 2017

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin resistanceMineralocorticoid receptor

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Post-ischemic Dilatation

    Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.

    Baseline and Week 6

Secondary Outcomes (4)

  • Change From Baseline in Para-aminohippurate (PAH) Clearance

    Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)

  • Change From Baseline in Markers of Inflammation

    Baseline and Week 6

  • Change From Baseline in Insulin Sensitivity Index (ISI)

    Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)

  • Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)

Study Arms (2)

Spironolactone

ACTIVE COMPARATOR
Drug: Spironolactone

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SpironolactoneDRUG

50 mg once daily for 6 weeks.

Spironolactone
PlaceboDRUG

Placebo-matching spironolactone once daily for 6 weeks.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Good health as evidenced by history and physical exam
  • Body Mass Index (BMI): \>30 kg/m2 and \<45 kg/m2

You may not qualify if:

  • Medical illnesses other than treated hypothyroidism
  • Blood Pressure (BP) \>135/85 or systolic BP \<90 mm Hg
  • Hepatic disease (transaminase \> 3 times normal)
  • Renal impairment (Creatinine clearance \<60 ml/min)
  • Baseline serum Potassium (K) \>5.0 mmol/L
  • History of drug or alcohol abuse
  • Allergies to spironolactone
  • Participation in any other concurrent clinical trial
  • Women using oral contraceptives within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.

    PMID: 24191286DERIVED

  • Garg R, Kneen L, Williams GH, Adler GK. Effect of mineralocorticoid receptor antagonist on insulin resistance and endothelial function in obese subjects. Diabetes Obes Metab. 2014 Mar;16(3):268-72. doi: 10.1111/dom.12224. Epub 2013 Oct 31.

    PMID: 24125483DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Rajesh K. Garg
Organization
Brigham and Women's Hospital
RGARG@bwh.harvard.edu

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 29, 2011

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

April 28, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-03

Locations

US(1)