Effect of Cabergoline on Weight and Glucose Tolerance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT01395602
First received: July 14, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Body Weight
Impaired Glucose Tolerance in Obese
Drug: Cabergoline
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2002
Study Completion Date: July 2011
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo pill
Other: placebo
1 pill twice weekly
Active Comparator: cabergoline
cabergoline pill
Drug: Cabergoline
cabergoline 0.5 mg twice weekly

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395602

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Judith Korner, MD, PHD Columbia University
  More Information

No publications provided

Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01395602     History of Changes
Other Study ID Numbers: 13952
Study First Received: July 14, 2011
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Glucose Intolerance
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Cabergoline
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014