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Bromocriptine and Insulin Sensitivity (BIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428946
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Insulin Sensitivity Drug: Bromocriptine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bromocriptine and Insulin Sensitivity in Lean and Obese Subjects
Study Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Morning bromocriptine
Bromocriptine is taken in the morning
 Drug: Bromocriptine
Investigating the randomized order for timing of bromocriptine administration
Other Name: Parlodel
Active Comparator: Evening bromocriptine
Bromocriptine is taken in te evening
 Drug: Bromocriptine
Investigating the randomized order for timing of bromocriptine administration
Other Name: Parlodel


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428946


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Frits Holleman, Dr. MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: F Holleman, Dr. MD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02428946    
Other Study ID Numbers: NL49417.018.14 METC 2014/147
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Insulin Sensitivity
obesity
dopamine
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bromocriptine
Antiparkinson Agents
 Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action