Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
Status unconfirmed · Not applicable
Conditions studied: Morbid Obesity
In brief
The purpose of this study is to find out more about the safety and effectiveness of the Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some of the other weight loss surgeries and it is possible that there are fewer risks with this procedure than with the other weight loss surgeries. LGCP is considered an experimental procedure and this study is being done to look at the long-term outcomes.
Key facts
- Study ID
- NCT02315105
- Run by
- Singh, Kuldeep, M.D., P.A.
- People needed
- 75
- Starts
- 2011-08-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2014-12-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is willing to give consent and comply with evaluation and treatment schedule
- 18 to 65 years of age
- Have a BMI > 30 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. these conditions include but are not limited to:
- Hyperlipidemia
- Type 2 diabetes
- Mild Obstructive Sleep Apnea
- Hypertension
- Osteoarthritis of the hip or knee
- Agree to refrain from any type of weight-loss drug ( prescription or OTC) or elective procedure that would affect body weight for the duration of the trial
- HbA1C < 11 %
- For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
- Ability to self-pay for the procedure and follow up.
Where it is running
- Saint Agnes Hospital — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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