Study of Tirzepatide for Adults With Obesity Without Diabetes and Adults With Type 2 Diabetes Evaluating Safety, Effectiveness, and Tolerability in Real-World Settings in Paraguay

What this Trial Is About

Researchers are evaluating the effects of tirzepatide on adults with obesity and adults with type 2 diabetes mellitus T2DM in Paraguay. This study aims to assess how well tirzepatide works and how safe and tolerable it is in real-world conditions, considering the unique genetics, diet, and lifestyle of the Paraguayan population. The study includes two groups one with obesity but no diabetes, and one with T2DM with or without obesity. All participants will receive tirzepatide injections once a week, starting at 2.5 mg with doses increased every 4 weeks as tolerated, following a standard schedule. Along with medication, participants will follow a high-protein, low-carbohydrate diet and a structured exercise plan to support weight loss and metabolic health. The study lasts 52 weeks, with visits approximately every 6 weeks, including evaluations like body composition, ultrasounds, muscle strength, and lab tests. Participants will be monitored closely for changes in body weight, HbA1c levels, and any side effects throughout the year. Body fat and muscle mass will be measured using bioelectrical impedance, and ultrasound scans of the abdomen and thyroid will be done at the start, halfway point, and end of the study. Safety is carefully tracked, especially for gastrointestinal and liver-related issues. The study excludes people using insulin to focus on tirzepatides effects as a primary treatment option.

Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.