Obesity Clinical Trial
— LETHEOfficial title:
Intensive Lifestyle Modifications With or Without Liraglutide 3 mg Versus Sleeve Gastrectomy: A 3 Arm Randomized Controlled Pilot Study (LETHE)
Verified date | May 2018 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background/Objectives: Only 1% of the clinically eligible subjects receive surgical treatment
for their obesity, thus other options should be investigated. In this study we aim to assess
the effect of intensive-lifestyle-modification(ILM) with or without Liraglutide-3mg daily
versus sleeve-gastrectomy(SG) on BMI at 1-year.
Subjects/Methods: In this study performed in a University Hospital in Italy, non-diabetic
patients eligible for bariatric-surgery are recruited from the weight loss clinic and have
the option to choose within three possible weight-loss programs up to complete the allocation
of 25 subjects in each arm matched by BMI and age. ILM consists in 600kcal
very-low-calorie-diet(VLCD) for 1 month followed by 12kcal/kgbw high-protein, high-fat-diet
for 11 months plus 30minutes brisk-walk daily and at least 3 hours aerobic-exercise weekly.
SG patients have 1-month VLCD and free-diet thereafter. Patients are evaluated at baseline
and at 1,3,6,9 and 12months.
Status | Completed |
Enrollment | 75 |
Est. completion date | April 10, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: Age ranging from 18 to 70 years, stable body weight in the previous 6 months body mass index (BMI expressed in kg/m2) >35 if comorbidity (hypertension, sleep apnea, severe hip or knee arthritis) are present or >40 kg/m2. Exclusion Criteria: Type 1 or 2 diabetes, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, a family or personal history of multiple endocrine cancer type 2 or familial medullary thyroid carcinoma. |
Country | Name | City | State |
---|---|---|---|
Italy | Catholic University School of Medicine | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of baseline BMI | percent variation of BMI with respect to baseline value | 1 year | |
Secondary | changes of baseline weight plasma | percent variation of variables with respect to baseline value | 1 year | |
Secondary | changes in body composition | percent variation of variables with respect to baseline value | 1 year | |
Secondary | changes in plasma glucose | percent variation of variables with respect to baseline value | 1 year | |
Secondary | changes in HOMA-IR | percent variation of variables with respect to baseline value | 1 year | |
Secondary | changes in blood pressure | percent variation of variables with respect to baseline value | 1 year | |
Secondary | changes in lipid profile | percent variation of variables with respect to baseline value | 1 year |
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