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Phase 3 Completed 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
Source: ClinicalTrials.gov NCT05405244 ↗
Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Ad Libitum Food and Beverage Intake (g) — 71.5; 81.9; 24.9; 33.6 g — p=0.45
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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