Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Study ID
NCT04325581
Phase
PHASE3
Status
Completed

Conditions

  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide 6 MG/ML — DRUG
    Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
  • Placebos — DRUG
    Normal Saline SC daily

Study Details

Investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese patients in a placebo controlled design.

Key Dates

First listed
Mar 27, 2020
Start date
Aug 1, 2016
Status verified
Mar 2020
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Post LSG with Liraglutude
    Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.
  • Placebo Comparator: Post LSG without Liraglutide
    Normal Saline in equivalent per day subcutaneously once a day

Primary Outcome Measure

Incretin change [ Time Frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy ]

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