Phase 3 N=55 Randomized Triple-blind Diagnostic

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

Overweight and Obesity · Eating Behavior

Bottom Line

View on ClinicalTrials.gov: NCT05405244 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Ad Libitum Food and Beverage Intake (g) — 71.5; 81.9; 24.9; 33.6 g — p=0.45

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Bromocriptine-QR (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Ad Libitum Food and Beverage Intake (g)	71.5; 81.9; 24.9; 33.6	0.45
PRIMARY Hedonic Ratings of Food as Measured by a Visual Analog Scale	32.6; 32.2; 11.2; 14.6; 22.7; 32.4	0.89
PRIMARY Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Milkshake Anticipation and Receipt vs. Water	50.24; 15.66; -14.32; 3.75	—
SECONDARY Ad Libitum Food and Milkshake Intake (g) by TaqIA Allele Status (A1 vs. A2/A2)	72.1; 70.7; 75.2; 91.4; 26.1; 23.3	—
SECONDARY Hedonic Ratings of Milkshake Pleasantness and Desire as Measured by a Visual Analog Scale by TaqIA Allele Status (A1 vs. A2/A2)	27.7; 15.1; 29.9; 12.2; 3.7; -18.1	—
SECONDARY 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)	99.14; -8.44; 71.54; -51.4; -27.21; 1.16	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05405244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.