Body WeightPhase 1/2NCT01395602
Effect of Cabergoline on Weight and Glucose Tolerance
A Phase 1/2 study testing Cabergoline in people with Body Weight and Impaired Glucose Tolerance in Obese, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Impaired Glucose Tolerance in Obese
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 - 55 years
- BMI 30 -40
Who cannot join
- diabetes,
- clinically significant medical condition,
- use of medications that effect blood glucose or body weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults
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.
- Conditions
- Body Weight, Impaired Glucose Tolerance in Obese
- Being tested
- Cabergoline, placebo
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
cabergoline 0.5 mg twice weekly
placeboOther
1 pill twice weekly
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo pill Receives: Other: placebo |
| cabergoline | Active comparator | cabergoline pill Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: 16 weeks
Secondary outcomes (1)
glucose
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startApr 2002
- Primary completionSep 2003
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Korner, Columbia University
- Investigators
- Judith Korner, MD, PHD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395602
- Sponsor's protocol ID
- IRB #13952
- Status last verified
- Oct 2015
- First submitted
- 14 Jul 2011
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults
- ClinicalTrials.gov ID
- NCT01395602
- Acronym / sponsor ID
- IRB #13952
- Conditions
- Body Weight, Impaired Glucose Tolerance in Obese
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placeboplacebo pill |
| cabergoline | Active comparator | Drug: Cabergolinecabergoline pill |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18 - 55 years
- BMI 30 -40
Key exclusion criteria (3 listed)
- diabetes,
- clinically significant medical condition,
- use of medications that effect blood glucose or body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergolinecabergoline 0.5 mg twice weekly | Drug | cabergoline |
| placebo1 pill twice weekly | Other | placebo |
Primary outcome
body weight
Time frame: 16 weeks
1 secondary outcome
glucose
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Korner, MD, PHD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cabergoline in people with Body Weight and Impaired Glucose Tolerance in Obese, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.