Effect of Intragastric Botulinum Type A Injection Combined with a Low-Calorie High-Protein Diet in Adults with Overweight or Obesity
Abstract
:1. Introduction
2. Materials and Methods
2.1. Endoscopic Procedures of IGBI
2.2. Definition and Assessment of Fatty Liver
2.3. Measures
2.4. End Points and Assessments
2.5. Safety Assessments
2.6. Statistical Analysis
3. Results
Change in Body Weight as End-Point Assessment
4. Safety Assessment
5. Discussion
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | IGBI (N = 49) | Placebo (N = 22) | p-Value |
---|---|---|---|
Age (years) | 39.8 (37.1–42.4) | 49.7 (43.1–56.3) | 0.007 |
Female sex, n (%) | 37 (76) | 16 (72) | 0.80 |
Weight (kg) | 82.1 (77.2–87.1) | 77.3 (70.7–83.8) | 0.25 |
BMI (kg/m2) | 29.3 (26.2–33.3) | 28.0 (26.8–30.8) | 0.63 |
Overweight, n (%) | 27 (55%) | 12 (54%) | 0.66 |
Obesity, n (%) | 22 (45%) | 10 (46%) | 0.66 |
Fatty liver stage, n (%) | 0.25 | ||
Mild | 9 (18%) | 3 (13%) | |
Moderate | 9 (18%) | 5 (22%) | |
Severe | 27 (55%) | 14 (63.6%) | |
HBA1c (%) | 5.5 (5.4–5.6) | 5.5 (5.3–5.7) | 0.49 |
Cholesterol (mg/dL) | |||
Total | 164.1 (155.4–172.7) | 186.0 (164.1–207.9) | 0.005 |
HDL cholesterol | 43.5 (37.6–49.4) | 51.8 (43.2–60.5) | 0.11 |
LDL cholesterol | 100.1 (92.7–107.5) | 134.2 (113.8–154.5) | 0.003 |
Triglycerides (mg/dL) | 112.9 (82.8–143.0) | 158.6 (132.0–185.2) | 0.02 |
Adverse Event | IGBI (49) | Placebo (22) |
---|---|---|
Time to any adverse event, weeks | 1 (1–2) | 1 (1) |
Any adverse event, no (%) | 20 (40.8) | 2 |
Serious adverse events, no (%) | 0(0) | 0 |
Reported adverse evet, no. (%) | ||
Nausea | 2 (4.0) | 0 |
Vomiting | 0(0) | 0 |
Diarrhea | 1 (2.0) | 0 |
Constipation | 12 (24.4) | 2 (9.0) |
Nasopharyngitis | 2 (4.0) | 0 |
Urinary disorder | 1 (2.0) | 0 |
Abdominal pain | 1 (2.0) | 0 |
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Hsu, P.-K.; Wu, C.-L.; Yang, Y.-H.; Wei, J.C.-C. Effect of Intragastric Botulinum Type A Injection Combined with a Low-Calorie High-Protein Diet in Adults with Overweight or Obesity. J. Clin. Med. 2022, 11, 3325. https://doi.org/10.3390/jcm11123325
Hsu P-K, Wu C-L, Yang Y-H, Wei JC-C. Effect of Intragastric Botulinum Type A Injection Combined with a Low-Calorie High-Protein Diet in Adults with Overweight or Obesity. Journal of Clinical Medicine. 2022; 11(12):3325. https://doi.org/10.3390/jcm11123325
Chicago/Turabian StyleHsu, Po-Ke, Chia-Lin Wu, Yu-Hsuan Yang, and James Cheng-Chung Wei. 2022. "Effect of Intragastric Botulinum Type A Injection Combined with a Low-Calorie High-Protein Diet in Adults with Overweight or Obesity" Journal of Clinical Medicine 11, no. 12: 3325. https://doi.org/10.3390/jcm11123325