crossover randomized trial
Braini-Ex
The Effect of GLP-1 Receptor Activation on Central Reward and Satiety Circuits in Response to Food Stimuli in Obesity and Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | exenatide Exenatide intravenous infusion | somatostatin pancreatic clamp; lifestyle: none | 48 | ||
| A2 | exenatide Exenatide plus exendin 9-39 infusion | somatostatin pancreatic clamp; lifestyle: none | 48 | ||
| A3 | Placebo Saline placebo infusion | somatostatin pancreatic clamp; lifestyle: none | 48 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide intravenous infusion A1 | Exenatide plus exendin 9-39 infusion A2 | Placebo A3 | Whole trial ALL |
|---|---|---|---|---|---|
| age group:lean | mean (years) | 57.8 | |||
| age group:lean | se (years) | 1.9 | |||
| age group:obese | mean (years) | 57.6 | |||
| age group:obese | se (years) | 2.2 | |||
| age group:t2dm | mean (years) | 61.4 | |||
| age group:t2dm | se (years) | 1.5 | |||
| bmi group:lean | mean (kg/m2) | 23.2 | |||
| bmi group:lean | se (kg/m2) | 0.4 | |||
| bmi group:obese | mean (kg/m2) | 32.5 | |||
| bmi group:obese | se (kg/m2) | 0.8 | |||
| bmi group:t2dm | mean (kg/m2) | 34.0 | |||
| bmi group:t2dm | se (kg/m2) | 0.9 | |||
| diabetes duration group:t2dm | median (years) | 7.0 | |||
| diabetes duration group:t2dm | q1 (years) | 4.25 | |||
| diabetes duration group:t2dm | q3 (years) | 10.75 | |||
| female group:lean | n | 8 | |||
| female group:obese | n | 7 | |||
| female group:t2dm | n | 8 | |||
| hba1c group:lean | mean (percent) | 5.5 | |||
| hba1c group:lean | se (percent) | 0.03 | |||
| hba1c group:obese | mean (percent) | 5.6 | |||
| hba1c group:obese | se (percent) | 0.07 | |||
| hba1c group:t2dm | mean (percent) | 6.9 | |||
| hba1c group:t2dm | se (percent) | 0.22 | |||
| other metformin monotherapy group:t2dm | n | 8 | |||
| other metformin plus sulfonylurea group:t2dm | n | 8 | |||
| sbp group:lean | mean (mmHg) | 120 | |||
| sbp group:lean | se (mmHg) | 4 | |||
| sbp group:obese | mean (mmHg) | 126 | |||
| sbp group:obese | se (mmHg) | 3 | |||
| sbp group:t2dm | mean (mmHg) | 141 | |||
| sbp group:t2dm | se (mmHg) | 3 | |||
| waist group:lean | mean (cm) | 85.5 | |||
| waist group:lean | se (cm) | 1.9 | |||
| waist group:obese | mean (cm) | 111.9 | |||
| waist group:obese | se (cm) | 2.1 | |||
| waist group:t2dm | mean (cm) | 115.7 | |||
| waist group:t2dm | se (cm) | 1.8 | |||
| weight group:lean | mean (kg) | 71.1 | |||
| weight group:lean | se (kg) | 2.7 | |||
| weight group:obese | mean (kg) | 100.2 | |||
| weight group:obese | se (kg) | 3.0 | |||
| weight group:t2dm | mean (kg) | 97.9 | |||
| weight group:t2dm | se (kg) | 3.0 |
Results
2 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / | not stated; other; group:lean; nausea and vomiting; R0023304:p6 | ||||
| A1 | events | 2 / | not stated; other; group:obese; nausea and vomiting; R0023304:p6 |