NCT00276471已完成1 期
Evaluation of the Tantalus System in Type 2 Diabetic Subjects
MetaCure Limited2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Evaluation of blood chemistry, hematology and urinalysis
研究概览
简要总结
Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM subjects inadequately controlled on a maximum of three oral agents
- •Subjects with HbA1c between 7 and 9%
- •Subjects with FBG between 120 and 200 mg/dL
- •Subjects who are 21-60 years old
- •Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
- •Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
- •Subjects with waist circumference >94 cm (males) and >80 cm (females)
- •Subjects on stable medication program for at least three months with any oral medication program
- •Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
- •Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
- •Able to provide voluntary informed consent.
排除标准
- •Subjects at high risk of general anesthesia or surgery
- •Subjects with prior pancreatitis
- •Subjects with chronic hepatitis
- •Subjects with elevated serum creatinine
- •Subjects with proliferative diabetic retinopathy
- •Subjects with gastroparesis or intestinal pseudo-obstruction
- •Subjects with motility disorders of the GI tract
- •Subjects who are receiving medications known to affect gastric motility
- •Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
- •Subjects who are pregnant (proven by positive hCG), or lactating
- •Subjects who have had prior bariatric surgery
- •Subjects with a history of peptic ulcer disease
- •Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
- •Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
- •Subjects with a life-threatening co-morbidity or life expectancy of less than one year
- •Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
- •Subjects with a history of malignant disease
- •Subjects who are currently on chemotherapy treatment
结局指标
主要结局
Evaluation of blood chemistry, hematology and urinalysis
Ability to record electrical activity from the stomach
Evaluation of the of device and/or procedure related adverse events
Ability to communicate between patient wand and the device.
次要结局
- Significant decrease in the HbA1c values between baseline and end-of-treatment
- Reduction in the required medications due to improved glycemia.
- Significant reduction in weight loss between baseline and end-of-treatment
- Improvement in co-morbid parameters
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized StudyOverweightType 2 Diabetes MellitusNCT00547482MetaCure (USA), Inc.300
已完成
不适用
The TANTALUS® II for the Treatment of Type 2 DiabetesDiabetes Mellitus, Type 2NCT01303302MetaCure (USA), Inc.51
已完成
3 期
A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)Type 2 Diabetes MellitusNCT02791490Merck Sharp & Dohme LLC458
已完成
2 期
Pilot Study of Vedic Medicine for Type 2 DiabetesDiabetes Mellitus, Type 2NCT00065650National Center for Complementary and Integrative Health (NCCIH)60
已完成
2 期
A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or ThiazolidinedioneDiabetes Mellitus, Type 2NCT00743002OPKO Health, Inc.87