Metabolism and Bariatric Surgery Study

NCT03371368 | Completed DMC

• 2 other identifiers: AAAR3662R01DK072011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Insulin Resistance; Obesity

Keywords

Obesity; Insulin Resistance; Bariatric Surgery; Gastric Bypass; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Change in urine free cortisol level

  A linear mixed effects model will be used to compare the cortisol changes between the LCD and the surgery groups. Specifically, cortisol change will be modeled as longitudinal outcome, and the main predictors are time and treatment group, and the time-treatment interaction.

  Baseline and 1 year

Study Arms (5)

Gastric Bypass Diabetic and Non-diabetic

OTHER

Roux-en-Y gastric bypass surgery

Procedure: Roux-en-Y Gastric Bypass (RYGBP)

Sleeve Gastrectomy Diabetic and Non-diabetic

OTHER

sleeve gastrectomy surgery

Procedure: Sleeve Gastrectomy (SG)

Very Low Calorie Diet Diabetic and Non-diabetic

ACTIVE COMPARATOR

very low calorie diet

Behavioral: Very Low Calorie Diet (VLCD)

Obese Control Group

NO INTERVENTION

Non-diabetic obese subjects

Lean Control Group

NO INTERVENTION

Non-diabetic lean subjects

Interventions

Roux-en-Y Gastric Bypass (RYGBP) PROCEDURE

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

Also known as: RYGBP

Gastric Bypass Diabetic and Non-diabetic

Sleeve Gastrectomy (SG) PROCEDURE

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

Also known as: SG

Sleeve Gastrectomy Diabetic and Non-diabetic

Very Low Calorie Diet (VLCD) BEHAVIORAL

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

Also known as: VLCD

Very Low Calorie Diet Diabetic and Non-diabetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women Ages 18-65 Years Old

You may not qualify if:

• Altered Sleep-wake Cycle
• Type 1 or 2 Diabetes
• Previous Bariatric Surgery
• Lactose Intolerance
• Any Special Diet restrictions.
• Use of medications that may affect body weight at screening or during a 3-month period prior.
• Untreated thyroid disease
• Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.
• Pregnancy
• Tobacco or opioid use
• Alcohol dependence
• \> 3% weight change over the 3month period prior to screening
• Unwillingness to maintain current level of physical activity over duration of study period

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Judith Korner, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine at the Columbia University Medical Center

Model Details: Cohort

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 13, 2017
• Study Start: October 16, 2017
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)