Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT05405244
• Collaborator: American Diabetes Association (Other)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The current project applies an integrative three-prong approach to investigate the potential of the dopamine D2 receptor (DRD2) agonist bromocriptine to: 1) increase homeostatic satiation signaling, 2) alter neural circuitry to reduce hedonically motivated food intake, and 3) examines a genetic predisposition that may markedly impact the effectiveness of this medication in those at high risk for T2DM.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Eating Behavior	Drug: Placebo; Drug: Bromocriptine-QR	Phase 3

Detailed Description

Twenty-nine million Americans have diagnosed type 2 diabetes (T2DM), with fewer than half able to meet treatment goals and considerably more are at risk for development of T2DM. Implementation of healthy eating behavior has been identified as a barrier to T2DM treatment and efficacy. The determinants of eating behavior and weight regulation involve a complex interaction among individual-level homeostatic, hedonic, and genetic systems, and the external food environment. The high prevalence of obesity and T2DM suggests hedonic motivation to consume food overrides homeostatic satiation signaling, resulting in excess food intake. Elevated intake increases body mass and promotes T2DM incidence via dysregulation of glucagon-like peptide 1 (GLP-1), amylin, and adiponectin, which in turn can negatively impact T2DM treatment options.

Use of a pharmaceutical, such as bromocriptine, to aid in behavioral change is a novel method for treating and ameliorating T2DM and warrants investigation given that previous work has shown reward response to food images mediates T2DM control. Use of functional magnetic resonance imaging (fMRI) techniques to predict and evaluate hedonically-motivated eating behavior can be used to measure sensitivity to reward, and the role it plays in developing obesity, and is therefore an excellent tool to examine the associations among bromocriptine, satiety hormones, reward sensitivity and eating behavior.

Moreover, since 20-35% of the population carries the DRD2 TaqIA A1 allele, and 65% of the population is overweight or obese and at high risk for T2DM development or currently diagnosed, as much as 23% of the population may greatly benefit from dopamine agonist treatment. Despite the possibility that bromocriptine may have robust impact on T2DM treatment or as prevention therapy in those that are genetically predisposed, few data are available that directly examine the three systems (homeostatic, hedonic, genetic) available to assess whether a genetically-informed, personalized T2DM treatment is viable.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants are randomly assigned to one of two possible intervention arms (active drug vs. placebo) at baseline. Following a 2-week washout period, participants receive the other intervention.Participants are randomly assigned to one of two possible intervention arms (active drug vs. placebo) at baseline. Following a 2-week washout period, participants receive the other intervention.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Multimodel Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for Type 2 Diabetes
• Actual Study Start Date: Sep 19, 2017
• Actual Primary Completion Date: Sep 19, 2019
• Actual Study Completion Date: Sep 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Bromocriptine, then Placebo During the first intervention visit, participants receive a single dose of 1.6mg of bromocriptine (2 0.8mg capsules). Following a 2-week washout period, participants return for the second intervention visit, where they receive 2 capsules of placebo (sugar free calcium supplement) matched in shape (circle) and color (white) to bromocriptine. Both bromocriptine and placebo are administered orally.	Drug: Placebo; 2 capsules, orally administered once; Other Names: placebo (calcium supplement) ; Drug: Bromocriptine-QR; 1.6mg (2 0.8mg capsules), orally administered once; Other Names: quick-release (QR) bromocriptine (cycloset)
Other: Placebo, then Bromocriptine During the first intervention visit, participants receive 2 capsules of placebo (sugar free calcium supplement). Following a 2-week washout period, participants return for the second intervention visit, where they receive a single dose of 1.6mg of bromocriptine (2 0.8mg capsules). Both bromocriptine and placebo are administered orally.	Drug: Placebo; 2 capsules, orally administered once; Other Names: placebo (calcium supplement) ; Drug: Bromocriptine-QR; 1.6mg (2 0.8mg capsules), orally administered once; Other Names: quick-release (QR) bromocriptine (cycloset)

Outcome Measures

Primary Outcome Measures

1. Ad Libitum Food and Beverage Intake (g) [Within 15 minutes of completion of the ad libitum period]

   Ad libitum food intake of highly-palatable snacks is assessed during each intervention arm. Participants are left alone for 25 minutes to eat as much as they want from a selection of snacks (M&Ms, Skittles, Doritos, cheddar popcorn) and a chocolate milkshake. Both snacks and milkshake are pre- and post-weighed to determine ad libitum food intake.

2. Hedonic Ratings of Food as Measured by a Visual Analog Scale [Up to 5 minutes prior to ad libitum period start]

   Testing the effects of the drug on hedonic ratings (pleasantness, desire to consume) of milkshake and snacks on a scale from -100 to 100. Pleasantness was assessed by asking 'How pleasant is this taste?', with responses ranging from -100 (most unpleasant imaginable) to 100 (most pleasant imaginable). Desire to consume was assessed by asking 'How much would you want to eat/drink this?', with responses ranging from -100 (least desirable imaginable) to 100 (most desirable imaginable).

3. Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Milkshake Anticipation and Receipt vs. Water [Baseline and 2 Weeks]

   The fMRI paradigm assesses evoked BOLD response to cue-elicited anticipation and receipt of a milkshake and water. A region-of-interest (ROI) approach will be used to assess changes in BOLD response (parameter estimates of brain response; arbitrary units) in the striatum. The striatal response will be assessed for the two contrasts of interest: milkshake>h2o anticipation and milkshake>h2o receipt. Parameter estimates of the relative BOLD brain response to each of these contrasts will be extracted and compared between the two arms. Each trial in the paradigm starts with the presentation of a cue (duration: 1s) signaling the impending delivery of either 3 mL of highly palatable milkshake or a control water solution over a period of 6s. Taste delivery is followed by a 1s wait period and 2s rinse (tasteless solution). The next trial begins after a 1-9s jitter. Order of milkshake and water trials is pseudo-randomized. In total, there are 64 trials (32 trials per run).

Secondary Outcome Measures

1. Ad Libitum Food and Milkshake Intake (g) by TaqIA Allele Status (A1 vs. A2/A2) [Within 15 minutes of completion of the ad libitum period]

   Testing the drug by gene (TaqIA) interaction on ad libitum food intake (g).The presence of the high-risk A1 allele of the TaqIA polymorphism (rs1800497) in the DRD2 gene was determined from saliva samples and is compared to the A2/A2 variant.

2. Hedonic Ratings of Milkshake Pleasantness and Desire as Measured by a Visual Analog Scale by TaqIA Allele Status (A1 vs. A2/A2) [Up to 5 minutes prior to ad libitum period start]

   Testing the drug by gene (TaqIA) interaction on hedonic ratings (pleasantness, desire to consume) of milkshake on a scale from -100 to 100. Testing the drug by gene (TaqIA) interaction on ad libitum milkshake (g). The presence of the high-risk A1 allele of the TaqIA polymorphism (rs1800497) in the DRD2 gene was determined from saliva samples and is compared to the A2/A2 variant. Pleasantness was assessed by asking 'How pleasant is this taste?', with responses ranging from -100 (most unpleasant imaginable) to 100 (most pleasant imaginable). Desire to consume was assessed by asking 'How much would you want to eat/drink this?', with responses ranging from -100 (least desirable imaginable) to 100 (most desirable imaginable).

3. Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Milkshake Anticipation and Receipt vs. Water by TaqIA Allele Status (A1 vs. A2/A2) [Baseline and 2 Weeks]

   The fMRI paradigm assesses evoked BOLD response to cue-elicited anticipation and receipt of a milkshake and water. A region-of-interest (ROI) approach will be used to assess changes in BOLD response (parameter estimates of brain response; arbitrary units) in the striatum. The striatal response will be assessed for the two contrasts of interest: milkshake>h2o anticipation and milkshake>h2o receipt. Parameter estimates of the relative BOLD brain response to these contrasts will be extracted and used to test the drug by gene (TaqIA) interaction. Each trial in the paradigm starts with the presentation of a cue (duration: 1s) signaling the impending delivery of either 3 mL of highly palatable milkshake or a control water solution over a period of 6s. Taste delivery is followed by a 1s wait period and 2s rinse (tasteless solution). The next trial begins after a 1-9s jitter. Order of milkshake and water trials is pseudo-randomized. In total, there are 64 trials (32 trials per run).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Baseline BMI between 25 and 35

Exclusion Criteria:

• Individuals with current fMRI contraindications (e.g., metal implants, braces)

• Probable current Axis I psychopathology (e.g., major depression disorder, panic disorder, generalized anxiety disorder, bipolar disorder)

• Habitual use of cigarettes or illicit drugs

• Pregnancy or breastfeeding

• Diagnosis of serious medical problems (e.g., diabetes, cardiovascular disease, stroke)

• Current weight loss dieting and/or weight fluctuations great than 10 lbs in the previous 6 weeks

• Do not consume dairy

• Allergy to bromocriptine, dairy, and nuts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• American Diabetes Association

Investigators

• Principal Investigator: Kyle S Burger, MPH, RD, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol - Jun 6, 2022
• Statistical Analysis Plan - Jun 9, 2022

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT05405244
• Other Study ID Numbers: 16-3177; 1-17-JDF-031
• First Posted: Jun 6, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by University of North Carolina, Chapel Hill: bromocriptine; dopamine agonist; TaqIA polymorphism; eating behavior; food intake; overweight; obesity
• Additional relevant MeSH terms: Overweight; Bromocriptine

Study Results

Participant Flow

Arm/Group Title	Bromocriptine, Then Placebo	Placebo, Then Bromocriptine
Arm/Group Description	During the first intervention visit, participants receive a single dose of 1.6mg of bromocriptine (2 0.8mg capsules). Following a 2-week washout period, participants return for the second intervention visit, where they receive 2 capsules of placebo (sugar free calcium supplement) matched in shape (circle) and color (white) to bromocriptine. Both bromocriptine and placebo are administered orally. Placebo: 2 capsules, orally administered once Bromocriptine-QR: 1.6mg (2 0.8mg capsules), orally administered once	During the first intervention visit, participants receive 2 capsules of placebo (sugar free calcium supplement). Following a 2-week washout period, participants return for the second intervention visit, where they receive a single dose of 1.6mg of bromocriptine (2 0.8mg capsules). Both bromocriptine and placebo are administered orally. Placebo: 2 capsules, orally administered once Bromocriptine-QR: 1.6mg (2 0.8mg capsules), orally administered once
Period Title: First Intervention (Single 1-Day Visit)
STARTED	28	27
COMPLETED	28	27
NOT COMPLETED	0	0
Period Title: First Intervention (Single 1-Day Visit)
STARTED	28	27
COMPLETED	24	26
NOT COMPLETED	4	1
Period Title: First Intervention (Single 1-Day Visit)
STARTED	24	26
COMPLETED	24	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Cross-over design where participants receive either a single dose of bromocriptine or placebo at the initial visit. After a 2-week washout period, they receive the opposite drug at the cross-over visit.
Overall Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.4 (3.1)
Sex: Female, Male (Count of Participants)
Female	29 52.7%
Male	26 47.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 14.5%
Not Hispanic or Latino	47 85.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.8%
Asian	7 12.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 16.4%
White	31 56.4%
More than one race	2 3.6%
Unknown or Not Reported	5 9.1%
Region of Enrollment (Count of Participants)
United States	55 100%

Outcome Measures

1. Primary Outcome

Title	Ad Libitum Food and Beverage Intake (g)
Description	Ad libitum food intake of highly-palatable snacks is assessed during each intervention arm. Participants are left alone for 25 minutes to eat as much as they want from a selection of snacks (M&Ms, Skittles, Doritos, cheddar popcorn) and a chocolate milkshake. Both snacks and milkshake are pre- and post-weighed to determine ad libitum food intake.
Time Frame	Within 15 minutes of completion of the ad libitum period

Outcome Measure Data

Analysis Population Description

Data was collected via an iPad and sometimes recorded no value, as such the decrease in the sample was due to missing data.

Arm/Group Title	Bromocriptine	Placebo
Arm/Group Description	All participants; post-bromocriptine administration	All participants; post-placebo administration
Measure Participants	47	47
Snacks intake	71.5 (58.5)	81.9 (55.9)
Milkshake intake	24.9 (61.2)	33.6 (66.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bromocriptine, Placebo
	Comments	Snack intake
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bromocriptine, Placebo
	Comments	Milkshake intake
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Hedonic Ratings of Food as Measured by a Visual Analog Scale
Description	Testing the effects of the drug on hedonic ratings (pleasantness, desire to consume) of milkshake and snacks on a scale from -100 to 100. Pleasantness was assessed by asking 'How pleasant is this taste?', with responses ranging from -100 (most unpleasant imaginable) to 100 (most pleasant imaginable). Desire to consume was assessed by asking 'How much would you want to eat/drink this?', with responses ranging from -100 (least desirable imaginable) to 100 (most desirable imaginable).
Time Frame	Up to 5 minutes prior to ad libitum period start

Outcome Measure Data

Analysis Population Description

Data was collected via an iPad and sometimes recorded no value, as such the decrease in the sample was due to missing data.

Arm/Group Title	Bromocriptine	Placebo
Arm/Group Description	All participants; post-bromocriptine administration	All participants; post-placebo administration
Measure Participants	47	47
Snack Pleasantness	32.6 (15.8)	32.2 (15.9)
Snack Desire	11.2 (22.4)	14.6 (22.7)
Milkshake Pleasantness	22.7 (34.3)	32.4 (15.5)
Milkshake Desire	-5.1 (40.2)	-5.6 (41.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bromocriptine, Placebo
	Comments	Pleasantness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bromocriptine, Placebo
	Comments	Desire to consume
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Milkshake Anticipation and Receipt vs. Water
Description	The fMRI paradigm assesses evoked BOLD response to cue-elicited anticipation and receipt of a milkshake and water. A region-of-interest (ROI) approach will be used to assess changes in BOLD response (parameter estimates of brain response; arbitrary units) in the striatum. The striatal response will be assessed for the two contrasts of interest: milkshake>h2o anticipation and milkshake>h2o receipt. Parameter estimates of the relative BOLD brain response to each of these contrasts will be extracted and compared between the two arms. Each trial in the paradigm starts with the presentation of a cue (duration: 1s) signaling the impending delivery of either 3 mL of highly palatable milkshake or a control water solution over a period of 6s. Taste delivery is followed by a 1s wait period and 2s rinse (tasteless solution). The next trial begins after a 1-9s jitter. Order of milkshake and water trials is pseudo-randomized. In total, there are 64 trials (32 trials per run).
Time Frame	Baseline and 2 Weeks

Outcome Measure Data

Analysis Population Description

Participants who had issues with neuroimaging data (e.g., excessive motion, errors with image registration) were excluded from the analysis. As such the decrease in sample is due to suboptimal quality fMRI data.

Arm/Group Title	Bromocriptine	Placebo
Arm/Group Description	All participants; post-bromocriptine administration	All participants; post-placebo administration
Measure Participants	33	33
Milkshake cue > Water cue	50.24 (180.43)	15.66 (208.4)
Milkshake taste > Water taste	-14.32 (57.68)	3.75 (66.03)

4. Secondary Outcome

Title	Ad Libitum Food and Milkshake Intake (g) by TaqIA Allele Status (A1 vs. A2/A2)
Description	Testing the drug by gene (TaqIA) interaction on ad libitum food intake (g).The presence of the high-risk A1 allele of the TaqIA polymorphism (rs1800497) in the DRD2 gene was determined from saliva samples and is compared to the A2/A2 variant.
Time Frame	Within 15 minutes of completion of the ad libitum period

Outcome Measure Data

Analysis Population Description

Data was collected via an iPad and sometimes recorded no value, as such the decrease in the sample was due to missing data.

Arm/Group Title	Bromocriptine - TaqIA A1	Bromocriptine - TaqIA A2/A2	Placebo - TaqIA A1	Placebo - TaqIA A2/A2
Arm/Group Description	Participants with the high risk TaqIA A1 allele; post-bromocriptine administration	Participants without the high risk TaqIA A1 allele; post-bromocriptine administration	Participants with the high risk TaqIA A1 allele; post-placebo administration	Participants without the high risk TaqIA A1 allele; post-placebo administration
Measure Participants	28	19	28	19
Snacks intake	72.1 (64.3)	70.7 (50.2)	75.2 (46.1)	91.4 (67.7)
Milkshake intake	26.1 (57.9)	23.3 (67.2)	35.5 (66.7)	30.9 (67.1)

5. Secondary Outcome

Title	Hedonic Ratings of Milkshake Pleasantness and Desire as Measured by a Visual Analog Scale by TaqIA Allele Status (A1 vs. A2/A2)
Description	Testing the drug by gene (TaqIA) interaction on hedonic ratings (pleasantness, desire to consume) of milkshake on a scale from -100 to 100. Testing the drug by gene (TaqIA) interaction on ad libitum milkshake (g). The presence of the high-risk A1 allele of the TaqIA polymorphism (rs1800497) in the DRD2 gene was determined from saliva samples and is compared to the A2/A2 variant. Pleasantness was assessed by asking 'How pleasant is this taste?', with responses ranging from -100 (most unpleasant imaginable) to 100 (most pleasant imaginable). Desire to consume was assessed by asking 'How much would you want to eat/drink this?', with responses ranging from -100 (least desirable imaginable) to 100 (most desirable imaginable).
Time Frame	Up to 5 minutes prior to ad libitum period start

Outcome Measure Data

Analysis Population Description

Data was collected via an iPad and sometimes recorded no value, as such the decrease in the sample was due to missing data.

Arm/Group Title	Bromocriptine - TaqIA A1	Bromocriptine - TaqIA A2/A2	Placebo - TaqIA A1	Placebo - TaqIA A2/A2
Arm/Group Description	Participants with the high risk TaqIA A1 allele; post-bromocriptine administration	Participants without the high risk TaqIA A1 allele; post-bromocriptine administration	Participants with the high risk TaqIA A1 allele; post-placebo administration	Participants without the high risk TaqIA A1 allele; post-placebo administration
Measure Participants	28	19	28	19
Pleasantness	27.7 (2.5)	15.1 (38.8)	29.9 (29.7)	12.2 (27.8)
Desire	3.7 (38.8)	-18.1 (40.3)	16.6 (20.9)	-21.5 (36.2)

6. Secondary Outcome

Title	Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Milkshake Anticipation and Receipt vs. Water by TaqIA Allele Status (A1 vs. A2/A2)
Description	The fMRI paradigm assesses evoked BOLD response to cue-elicited anticipation and receipt of a milkshake and water. A region-of-interest (ROI) approach will be used to assess changes in BOLD response (parameter estimates of brain response; arbitrary units) in the striatum. The striatal response will be assessed for the two contrasts of interest: milkshake>h2o anticipation and milkshake>h2o receipt. Parameter estimates of the relative BOLD brain response to these contrasts will be extracted and used to test the drug by gene (TaqIA) interaction. Each trial in the paradigm starts with the presentation of a cue (duration: 1s) signaling the impending delivery of either 3 mL of highly palatable milkshake or a control water solution over a period of 6s. Taste delivery is followed by a 1s wait period and 2s rinse (tasteless solution). The next trial begins after a 1-9s jitter. Order of milkshake and water trials is pseudo-randomized. In total, there are 64 trials (32 trials per run).
Time Frame	Baseline and 2 Weeks

Outcome Measure Data

Analysis Population Description

Participants who had issues with neuroimaging data (e.g., excessive motion, errors with image registration) were excluded from the analysis. As such the decrease in sample is due to suboptimal quality fMRI data.

Arm/Group Title	Bromocriptine - TaqIA A1	Bromocriptine - TaqIA A2/A2	Placebo - TaqIA A1	Placebo - TaqIA A2/A2
Arm/Group Description	Participants with the high risk TaqIA A1 allele; post-bromocriptine administration	Participants without the high risk TaqIA A1 allele; post-bromocriptine administration	Participants with the high risk TaqIA A1 allele; post-placebo administration	Participants without the high risk TaqIA A1 allele; post-placebo administration
Measure Participants	18	15	18	15
Milkshake cue > Water cue	99.14 (139.86)	-8.44 (209.51)	71.54 (176.11)	-51.4 (229.74)
Milkshake taste > Water taste	-27.21 (41.91)	1.16 (70.73)	-14.64 (45.95)	25.82 (80.29)

Adverse Events

Time Frame	Following administration of initial study intervention at Visit 1 through completion of visit day and again starting with second intervention administration and continuing through study completion, a total of approximately 10 hours for both visits.
Arm/Group Title	Bromocriptine		Placebo
Arm/Group Description	Single dose of bromocriptine 1.6mg (2 0.8mg capsules)		2 capsules of placebo (sugar free calcium supplement) matched in shape (circle) and color (white) to bromocriptine
All Cause Mortality
	Bromocriptine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/51 (0%)
Serious Adverse Events
	Bromocriptine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Bromocriptine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/54 (3.7%)		0/51 (0%)
Gastrointestinal disorders
Vomiting	1/54 (1.9%)	1	0/51 (0%)	0
Nausea	1/54 (1.9%)	1	0/51 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.