Effect of Cabergoline on Weight and Glucose Tolerance

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01395602
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 111
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight; Impaired Glucose Tolerance in Obese	Drug: Cabergoline; Other: placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo placebo pill	Other: placebo; 1 pill twice weekly
Active Comparator: cabergoline cabergoline pill	Drug: Cabergoline; cabergoline 0.5 mg twice weekly

Outcome Measures

Primary Outcome Measures

1. body weight [16 weeks]

Secondary Outcome Measures

1. glucose [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Judith Korner, MD, PHD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT01395602
• Other Study ID Numbers: IRB #13952
• First Posted: Jul 15, 2011
• Last Update Posted: Oct 14, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Glucose Intolerance; Body Weight; Cabergoline

Study Results

No Results Posted as of Oct 14, 2015