Metabolism and Bariatric Surgery Study

NCT ID: NCT03371368

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2023-04-24

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.

Detailed Description

Weight loss (WL) improves obesity-related co-morbidities such as type 2 diabetes mellitus (DM). Unfortunately, WL through life-style interventions has a high degree of relapse and the lack of safe, effective and affordable therapies together with an increase in the prevalence of morbid obesity has led to a rise in bariatric procedures. Clinical trials in patients with DM show that improvements in glycemia vary between procedures and occur in the following order: Roux-en-Y gastric bypass (RYGB) > sleeve gastrectomy (SG) > laparoscopic adjustable gastric banding (LAGB) > medical/life-style therapy. This order mirrors the amount of WL with each intervention and is a major driver of glycemic improvement. The investigators have shown profound changes unique to RYGB and SG in levels of hormones that make up the "gut-brain" and "enteroinsular" axes. The association of some of these hormones with insulin sensitivity (IS) and glycemia, independent of WL strongly suggests that glycemic improvements after surgery occur in part through pathways that are distinct from just calorie restriction. This study builds on results showing that levels of fibroblast growth factor 19 (FGF19), a protein secreted by intestinal cells, are increased after RYGB and SG but not after low calorie diet (LCD). This difference may affect hormones that control the stress response to weight loss. The investigators will explore differences in hormones of the gut that affect appetite, body weight, and stress response in healthy lean and obese individuals. Obese individuals will also be studied before and after 15% body weight loss induced by LCD, RYGB or SG, and again at 1 year after study enrollment.

Conditions

Insulin Resistance; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastric Bypass Diabetic and Non-diabetic

Roux-en-Y gastric bypass surgery

Group Type: OTHER

Roux-en-Y Gastric Bypass (RYGBP)

Intervention Type: PROCEDURE

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

Sleeve Gastrectomy Diabetic and Non-diabetic

sleeve gastrectomy surgery

Group Type: OTHER

Sleeve Gastrectomy (SG)

Intervention Type: PROCEDURE

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

Very Low Calorie Diet Diabetic and Non-diabetic

very low calorie diet

Group Type: ACTIVE_COMPARATOR

Very Low Calorie Diet (VLCD)

Intervention Type: 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

Obese Control Group

Non-diabetic obese subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lean Control Group

Non-diabetic lean subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Roux-en-Y Gastric Bypass (RYGBP)

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

Intervention Type: PROCEDURE

Sleeve Gastrectomy (SG)

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

Intervention Type: PROCEDURE

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

Intervention Type: BEHAVIORAL

Other Intervention Names

RYGBP; SG; VLCD

Eligibility Criteria

Inclusion Criteria

Men and women Ages 18-65 Years Old

Exclusion Criteria

1. Altered Sleep-wake Cycle

2. Type 1 or 2 Diabetes

3. Previous Bariatric Surgery

4. Lactose Intolerance

5. Any Special Diet restrictions.

6. Use of medications that may affect body weight at screening or during a 3-month period prior.

7. Untreated thyroid disease

8. Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.

9. Pregnancy

10. Tobacco or opioid use

11. Alcohol dependence

12. > 3% weight change over the 3month period prior to screening

13. Unwillingness to maintain current level of physical activity over duration of study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Judith Korner

Professor of Medicine at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith Korner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

R01DK072011

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR3662

Identifier Type: -

Identifier Source: org_study_id