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Metabolism and Bariatric Surgery Study

NCT03371368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-07

No results posted yet for this study

Summary

The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall research plan is a non-randomized prospective study of 3 different weight loss (WL) interventions and a lean and an obese healthy control group.

Conditions

Interventions

PROCEDURE

Roux-en-Y Gastric Bypass (RYGBP)

This is a standard RYGBP procedure that would be performed clinically and is not research-specific.

PROCEDURE

Sleeve Gastrectomy (SG)

This is a standard SG procedure that would be performed clinically and is not research-specific.

BEHAVIORAL

Very Low Calorie Diet (VLCD)

Weight loss with calorie restricted liquid diet. Subjects will be placed on a 800 kcal/day diet with a meal replacement (Optifast) provided by the investigator for 12 weeks. Then, transitioning to a higher calorie diet intake up to a year. Subjects will be closely monitored by study dietitian

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Judith Korner, MD, PhD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2023-04-24
Completion
2023-04-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371368 on ClinicalTrials.gov