Insulin SensitivityBISNCT02428946
Bromocriptine and Insulin Sensitivity
A study testing Bromocriptine in people with Insulin Sensitivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Bromocriptine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian origin
- Subjects should be able and willing to give informed consent
- BMI range of 19-23 kg/m2 or BMI> 27 kg/2
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Insulin Sensitivity
- Being tested
- Bromocriptine
- Keywords
- Insulin Sensitivity, obesity, dopamine
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromocriptineDrug
Also called Parlodel
Investigating the randomized order for timing of bromocriptine administration
| Study group | Role | What they receive |
|---|---|---|
| Morning bromocriptine | Active comparator | Bromocriptine is taken in the morning Receives: Drug: Bromocriptine |
| Evening bromocriptine | Active comparator | Bromocriptine is taken in te evening Receives: Drug: Bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
Difference in insulin sensitivity between lean and obese males before and after the use of bromocriptin
To determine whether there are differential effects of bromocriptine treatment on insulin sensitivity in obese or lean healthy, Caucasian males
Measured: 6 weeks
Difference in energy expenditure in lean and obese before and after the use of bromocriptin
To determine whether the difference in timing of bromocriptine influences energy expenditure during thermoneutral conditions in Caucasian, lean and obese males
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frits Holleman, Dr. MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428946
- Sponsor's protocol ID
- NL49417.018.14 METC 2014/147
- Acronym
- BIS
- Status last verified
- May 2016
- First submitted
- 17 Oct 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromocriptine and Insulin Sensitivity in Lean and Obese Subjects
- ClinicalTrials.gov ID
- NCT02428946
- Acronym / sponsor ID
- BIS / NL49417.018.14 METC 2014/147
- Conditions
- Insulin Sensitivity
- Keywords
- Insulin Sensitivity, obesity, dopamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 2015 (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.
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.
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning bromocriptine | Active comparator | Drug: BromocriptineBromocriptine is taken in the morning |
| Evening bromocriptine | Active comparator | Drug: BromocriptineBromocriptine is taken in te evening |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian origin
- Subjects should be able and willing to give informed consent
- BMI range of 19-23 kg/m2 or BMI> 27 kg/2
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| BromocriptineAlso: ParlodelInvestigating the randomized order for timing of bromocriptine administration | Drug | Evening bromocriptine, Morning bromocriptine |
Primary outcome
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
2 secondary outcomes
Difference in insulin sensitivity between lean and obese males before and after the use of bromocriptin
Time frame: 6 weeks
Difference in energy expenditure in lean and obese before and after the use of bromocriptin
Time frame: 6 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 24 May 2016.
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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.
Frits Holleman, Dr. MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromocriptine in people with Insulin Sensitivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 8 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 24 May 2016. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Timing of administration of bromocriptine (time frame: 6 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 24 May 2016.