← Back to Search

Gastric Bypass vs. Diet for Type 2 Diabetes (RBD-T2D Trial)

N/A

Waitlist Available

Led By Samuel Klein, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 Diabetes

For Low-Calorie Diet group: BMI 34-55 kg/m², Type 2 Diabetes and Non-Diabetics, Signed informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (before and after targeted weight loss)

Awards & highlights

RBD-T2D Trial Summary

This trial will compare the effects of weight loss from gastric bypass surgery to weight loss from a low calorie diet on insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without type 2 diabetes.

Who is the study for?

This trial is for obese individuals with or without Type 2 Diabetes, having a BMI between 34-55 kg/m². They must not use tobacco, be pregnant/breastfeeding, have had previous intestinal surgery, significant organ dysfunction (other than diabetes), or take meds affecting metabolism. Exercise should be less than 90 minutes per week.Check my eligibility

What is being tested?

The study compares the effects of Roux-en-Y Gastric bypass (RYGB) surgery and a low-calorie diet on weight loss and metabolic health in obese patients. It looks at how each method affects insulin sensitivity in the liver and muscles, beta-cell function, and overall metabolic balance over a day.See study design

What are the potential side effects?

Potential side effects from RYGB may include nutritional deficiencies, digestive issues like nausea or vomiting, surgical complications such as infections or hernias. The low-calorie diet might lead to fatigue, hunger pangs, mood swings and could potentially cause gallstones if weight loss is rapid.

RBD-T2D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Type 2 Diabetes.

Select...

I have a BMI between 34-55, may or may not have Type 2 Diabetes, and agree to participate.

Select...

I am scheduled for weight loss surgery.

RBD-T2D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (before and after targeted weight loss)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (before and after targeted weight loss)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (before and after targeted weight loss) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in hepatic insulin sensitivity

Secondary outcome measures

Changes in 24-hour plasma free fatty acid profile

Changes in 24-hour plasma glucose profile

Changes in 24-hour plasma insulin profile

+7 more

RBD-T2D Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Roux-en-Y gastric bypass (RYGB)Experimental Treatment1 Intervention

Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.

Group II: Low-calorie dietActive Control1 Intervention

Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Roux-en-Y gastric bypass surgery

2010

N/A

~160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,639 Total Patients Enrolled

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

2,356 Previous Clinical Trials

4,314,996 Total Patients Enrolled

Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine

27 Previous Clinical Trials

2,151 Total Patients Enrolled

Media Library

Low-calorie diet Clinical Trial Eligibility Overview. Trial Name: NCT02207777 — N/A

Type 2 Diabetes Research Study Groups: Low-calorie diet, Roux-en-Y gastric bypass (RYGB)

Type 2 Diabetes Clinical Trial 2023: Low-calorie diet Highlights & Side Effects. Trial Name: NCT02207777 — N/A

Low-calorie diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT02207777 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research available to those younger than 65?

"Participants accepted into this medical trial will have to be between 25 and 65 years of age."

Answered by AI

Is this research endeavor now recruiting participants?

"According to clinicaltrials.gov, the recruitment period for this medical trial has now closed; it was initially posted on August 1st 2014 and last updated April 11th 2022. Nevertheless, 2410 other trials are actively enrolling patients as of today."

Answered by AI

Is my participation in this medical evaluation permissible?

"This medical study is seeking to recruit 70 individuals aged 25-65 who have type 2 diabetes mellitus. To qualify, candidates must have a Body Mass Index (BMI) between 34 and 55 kg/m² and be scheduled for bariatric surgery. Additionally, all participants are required to sign an informed consent before the trial begins."

Answered by AI