Dopaminergic Effects on Brown Adipose Tissue

NCT02428933 | Completed

• 1 other identifier: METC nr 2013_107
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will investigate the effect of dopamine (bromocriptine) on Brown Adipose Tissue in lean, young, healthy males. The investigators will also examine energy expenditure, body temperature and insulin sensitivity as measurements of Brown Adipose Tissue activity.

Conditions

Obesity

Keywords

Brown Adipose Tissue; Obesity; Insulin Sensitivity; Dopamine

Outcome Measures

Primary Outcomes (1)

• Difference in 18F-FDG uptake before and after using bromocriptin

  BAT activity is assessed with a FDG-PET CT scan

  17 months

Secondary Outcomes (3)

• Difference in energy expenditure before and after using bromocriptin

  17 months

• Difference in core body temperature before and after using bromocriptin

  17 months

• Difference in insulin sensitivity before and after using bromocriptin

  17 months

Study Arms (1)

Before and after bromocriptine

OTHER

Subjects will be investigated before and after the use of bromocriptine. They will use bromocriptine for two weeks in the evening (1.25mg/day during the first week and 2.5mg/day during the second week).

Drug: Bromocriptine

Interventions

Bromocriptine DRUG

The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself

Also known as: Parlodel

Before and after bromocriptine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Caucasian origin
• Subjects should be able and willing to give informed consent
• years old
• BMI range of 19-25 kg/m2

You may not qualify if:

• Renal failure (creatinine\>135mmol/l)
• Liver failure (AST/ (Alanine Aminotransferase) ALT \> 3 times higher than the normal upper value)
• Daily use of prescription medication
• Known hypersensitivity to bromocriptine, domperidone maleate or other ergot alkaloids.
• Uncontrolled hypertension
• Known history of coronary artery disease, or other severe cardiovascular conditions (such as a prolonged Qtc-time), or symptoms / history of severe psychiatric disorders.
• Known cardiac valvulopathy
• Prolactin-releasing pituitary tumor (prolactinoma).
• Cases where stimulation of the gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.
• Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Prior participation in a research protocol involving radiation exposure in the last 2 years

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frits Holleman, Dr. MD.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. MD.

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: April 29, 2015
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

NL (1)