NCT01395602

Brief Summary

The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults. This is a randomized double-blind placebo controlled study. Twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks. The effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_1

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

April 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

July 14, 2011

Last Update Submit

October 13, 2015

Conditions

Body WeightImpaired Glucose Tolerance in Obese

Outcome Measures

Primary Outcomes (1)

  • body weight

    16 weeks

Secondary Outcomes (1)

  • glucose

    16 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo pill

Other: placebo

cabergoline

ACTIVE COMPARATOR

cabergoline pill

Drug: Cabergoline

Interventions

CabergolineDRUG

cabergoline 0.5 mg twice weekly

cabergoline
placeboOTHER

1 pill twice weekly

placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 - 55 years
  • BMI 30 -40

You may not qualify if:

  • diabetes,
  • clinically significant medical condition,
  • use of medications that effect blood glucose or body weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Body Weight

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Judith Korner, MD, PHD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 15, 2011

Study Start

April 1, 2002

Primary Completion

September 1, 2003

Study Completion

July 1, 2011

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

US(1)