Bromocriptine and Insulin Sensitivity

NCT02428946 | Completed

• 1 other identifier: NL49417.018.14 METC 2014/147
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Keywords

Insulin Sensitivity; obesity; dopamine

Outcome Measures

Primary Outcomes (1)

• Timing of administration of bromocriptine

  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 Outcomes (2)

• Difference in insulin sensitivity between lean and obese males before and after the use of bromocriptin

  6 weeks

• Difference in energy expenditure in lean and obese before and after the use of bromocriptin

  6 weeks

Study Arms (2)

Morning bromocriptine

ACTIVE COMPARATOR

Bromocriptine is taken in the morning

Drug: Bromocriptine

Evening bromocriptine

ACTIVE COMPARATOR

Bromocriptine is taken in te evening

Drug: Bromocriptine

Interventions

Bromocriptine DRUG

Investigating the randomized order for timing of bromocriptine administration

Also known as: Parlodel

Evening bromocriptine; Morning bromocriptine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• 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, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

NL (1)