Safety and Efficacy of Oral Semaglutide in Patients with Type 2 Diabetes and Obesity: An Observational Study at a Tertiary Care Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in HbA1c (%) from baseline to the end of the study (to assess glycemic control).
研究概览
简要总结
Aim:The aim of the study is to evaluate the safety and efficacy of oral semaglutide in improving glycemic control and promoting weight reducton In patientse with type 2 diabetes and obesity.
Objectives:Main Objective:
To assess the efficacy of oral semaglutide in reducing HbA1c levels in South Indian patients with type 2 diabetes and obesity treated at a tertiary care hospital.
Secondary Objectives:1. To assess the degree of weight reduction achieved with treatment.2. To monitor and document any adverse events associated with oral semaglutide use in South Indian patients3. Record the incidence and types of adverse effects in this population.4. To determine patient adherence and satisfaction with oral semaglutide therapy over the study period..STUDY DESIGN: Observational Prospective Cohort Study
SAMPLE SIZE: The sample size for safety and efficacy of oral semaglutide was n=45.
EXPECTED OUTCOME OF THE STUDY**:**
The study is expected to demonstrate a significant reduction in HbA1c levels, likely around 1%, showing effective glycemic control in South Indian patients with type 2 diabetes and obesity. Clinically meaningful weight loss (5-10% of body weight) is also anticipated, alongside improvements in fasting blood glucose and cardiovascular risk factors such as blood pressure and lipid profiles.
The safety profile should be favorable, with gastrointestinal side effects like nausea and vomiting being the most common, and a low incidence of serious adverse events like hypoglycemia or pancreatitis. Subgroup analyses may reveal differences in efficacy based on age, gender, or baseline BMI.
The study will likely support oral semaglutide as an effective and safe treatment option, contributing to better management of diabetes and obesity in the South Indian population. These findings could guide clinical protocols in tertiary care hospitals.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults more than 18 years diagnosed with Type 2 diabetes with HbA1C 7 percent to 10 percent.
- •2 BMI more than 27 kg per m2 indicative of obesity.
排除标准
- •1 Type 1 diabetes or other severe comorbidities such as renal or liver disease.
- •2 Pregnant or breastfeeding women.
- •3 Patients currently on other GLP 1 receptor agonists insulin or weight loss medications.
结局指标
主要结局
Change in HbA1c (%) from baseline to the end of the study (to assess glycemic control).
时间窗: 1 Month
Change in body weight (kg or % reduction) from baseline to the end of the study (to evaluate weight loss).
时间窗: 1 Month
次要结局
- Safety & Tolerability:(Incidence of adverse events & Serious Adverse Events.)
研究者
Vengatesh S
Sri Ramachandra Institute of Higher Education and Research.