Bromocriptine and Insulin Sensitivity (BIS)

May 23, 2016 updated by: F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Bromocriptine and Insulin Sensitivity in Lean and Obese Subjects

In this study the investigators will examine the effect of dopamine (bromocriptine) on insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine whether the timing of bromocriptine administration has influence on insulin sensitivity.

To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks bromocriptine. In randomized order, they will use it in the morning or in the evening.

The investigators will examine insulin sensitivity by performing a 7-point oral glucose tolerance test.

Furthermore, the investigators will examine energy expenditure and subjects will keep track of their eating behaviour in the 3 days before each study visit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bromocriptine, a dopamine 2 receptor agonist, has recently been approved in the treatment of type 2 diabetes mellitus(DM2). Bromocriptine causes a significant improvement of fasting plasma glucose and Hba1C values. The exact mechanism of action of bromocriptine is still unknown.

Earlier, the investigators performed a study to show the effects of bromocriptine on brown adipose tissue (BAT) activity (the DEBAT study (Medisch Etische Toetsingscommissie) METC nr 2013_107). Namely, BAT, known for its capacity to dissipate excess energy, might have been involved in this process as stimulation by the sympathetic nervous system is the principal driving force in controlling BAT activity. However, the investigators have shown that bromocriptine did not influence BAT activity or energy expenditure in healthy, lean subjects.

The investigators did found an effect of bromocriptine on insulin sensitivity unexpectedly, subjects became significantly less insulin sensitive after bromocriptine use.

Circadian neuroendocrine rhythms, especially the dopaminergic and serotonergic neurotransmitter activity, play a pivotal role in the development of seasonal and non-seasonal changes in body fat stores and insulin sensitivity. Therefore, the timing of bromocriptine administration might be of great importance in changes in insulin sensitivity. Indeed, in the treatment for DM2, a bromocriptine quick release variant is given in the morning. In the former study the investigators instructed the subjects to use the bromocriptine in the evening in combination with the evening meal. The investigators decided to do so because bromocriptine had to be taken in combination with food. The investigators wanted a high level of dopamine just before the 18F-Fludeoxyglucose(18F-FDG) positron emission tomography (PET) computed tomography (CT) scan to get a maximum effect of dopamine on BAT. But the subjects had to be fasted for the OGTT and 18F-FDG-PET-CT scan. Therefore, the investigators decided to give the (long-acting) bromocriptine in the evening.

Also, the effect of bromocriptine might be different in lean or obese subjects. Obesity is associated with an increased sympathetic tonus. Therefore, the baseline condition is different in lean or obese subjects which may cause different effects of bromocriptine treatment.

In this study the investigators aim to investigate whether the timing (e.g. morning or evening) of bromocriptine administration (1,25mg/day during the first week and 2,50mg/day during the second week) has different effects on insulin sensitivity in both lean and obese males.

At visit 1: Informed consent, medical history, vital signs and laboratory measurements will be obtained. The investigators will also perform an oral glucose tolerance test (OGTT), and an energy expenditure(EE) measurement after 60 minutes bed rest.

After visit 1: subjects will start using bromocriptine (1,25mg/day during the first week and 2,50mg/day during the second week) randomization to timing: in the morning or evening.

Visit 2: EE after 60 minutes rest. OGTT. 2 weeks washout period Visit 3: EE after 60 minutes rest. OGTT. After visit 3: start using bromocriptine (1,25mg/day during the first week and 2,50mg/day during the second week) at other time point.

Visit 4: EE after 60 minutes rest. OGTT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasian origin
  • Subjects should be able and willing to give informed consent
  • BMI range of 19-23 kg/m2 or BMI> 27 kg/2

Exclusion Criteria:

  • Renal failure (creatinine>135mmol/l)
  • Liver failure (ASAT/ALAT > 3 times higher than the normal upper value)
  • Daily use of prescription medication
  • Known hypersensitivity to bromocriptine.
  • Uncontrolled hypertension
  • Known history of coronary artery disease or valvulopathy
  • History of severe psychiatric disorders.
  • Prolactin-releasing pituitary tumor (prolactinoma).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Morning bromocriptine
Bromocriptine is taken in the morning
Drug: Bromocriptine
Investigating the randomized order for timing of bromocriptine administration
Other Names:
  • Parlodel
ACTIVE_COMPARATOR: Evening bromocriptine
Bromocriptine is taken in te evening
Drug: Bromocriptine
Investigating the randomized order for timing of bromocriptine administration
Other Names:
  • Parlodel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timing of administration of bromocriptine
Time Frame: 6 weeks
To determine whether there is a beneficial effect on insulin sensitivity when bromocriptine is given in the morning, as compared to bromocriptine in the evening in Caucasian, lean and obese males
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in insulin sensitivity between lean and obese males before and after the use of bromocriptin
Time Frame: 6 weeks
To determine whether there are differential effects of bromocriptine treatment on insulin sensitivity in obese or lean healthy, Caucasian males
6 weeks
Difference in energy expenditure in lean and obese before and after the use of bromocriptin
Time Frame: 6 weeks
To determine whether the difference in timing of bromocriptine influences energy expenditure during thermoneutral conditions in Caucasian, lean and obese males
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frits Holleman, Dr. MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL49417.018.14 METC 2014/147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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