CTRI/2020/02/023329尚未招募3 期
Evaluation of effectiveness of oral Teneligliptin on obesity, lipid profile, Insulin resistance & Quality of life among obesity and overweight participants - OLIQ
Self financed0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Body mass index (BMI) >= 30 kg/m2 or >= 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated):
- •Mild to Moderate Hypertension
- •Dyslipidemia
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •1.Glycemic related:
- •HbA1C >= 48 mmol/mol (6.5%) at screening
- •Treatment with glucose lowering agent (s) within 90 days before screening
- •Treatment with a DPP-4 inhibitors or GLP-1 receptor agonists within 180 days of before screening.
- •2.Obesity related:
- •A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Treatment with any medication for the indication of obesity within the past 90 days before screening
- •Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
- •liposuction and/or abdominoplasty, if performed > 1 year before screening
- •lap banding, if the band has been removed > 1 year before screening
- •Intragastric balloon, if the balloon has been removed > 1 year before screening
- •Duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening
- •Gastrointestinal surgeries that induces mal absorption
- •Indication of liver diseases (elevated ALT/AST or ALP)
- •History of pancreatitis
- •Uncontrolled thyroid disease (TSH > 6.0 mIU/L or < 0.4 mIU/L)
- •Severe Hypertension
- •Severe Obstructive sleep apnoea or cardiovascular disease
- •Psychological related:
- •History of major depressive disorder within 2 years before screening
- •Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •A Patient Health Questionnaire-9 (PHQ-9) score of >= 15 at screening
- •A lifetime history of a suicidal attempt
- •Suicidal behavior within 30 days before screening
- •Pregnant / lactating women
- •Patients on assistance of use of contraceptive pills
- •Patients receiving treatment with systemic corticosteroids
研究者
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