Effect of Cabergoline on Weight and Glucose Tolerance

Body Weight Clinical Trial

Official title:

Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395602
• Other study ID #: IRB #13952
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 14, 2011
• Last updated: October 13, 2015
• Start date: April 2002
• Est. completion date: July 2011

Study information

• Verified date: October 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• age 18 - 55 years

• BMI 30 -40

Exclusion Criteria:

• diabetes,

• clinically significant medical condition,

• use of medications that effect blood glucose or body weight

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Body Weight
• Glucose Intolerance
• Impaired Glucose Tolerance in Obese

Intervention

Drug:
• Cabergoline
cabergoline 0.5 mg twice weekly

Other:
• placebo
1 pill twice weekly

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		16 weeks	No
Secondary	glucose		16 weeks	No