What side effects are associated with this type of intervention?

Roux-en-Y Gastric Bypass (RYGB) can lead to significant weight loss and improvement in glycemic control but may also cause complications such as nutrient deficiencies, dumping syndrome, and surgical risks like infections or hernias. Low-Calorie Diets (LCD) are effective for weight loss and improving insulin sensitivity but can result in side effects like gallstones, nutrient deficiencies, and potential muscle loss if not properly managed. Both treatments require careful medical supervision to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that focus on weight loss, similar to the effects of Roux-en-Y Gastric Bypass and Low-Calorie Diet. GLP-1 receptor agonists such as liraglutide and semaglutide are notable for their dual role in improving glycemic control and promoting weight loss. Other approved weight loss medications include phentermine and combination therapies like phentermine-topiramate, which are used to manage obesity and its metabolic consequences. These pharmacological treatments provide alternative or complementary options to surgical and dietary interventions for managing Type 2 Diabetes.

What other types of research exist?

Promising, novel alternatives to Roux-en-Y Gastric Bypass and Low-Calorie Diet for Type 2 Diabetes patients include: 1) Laparoscopic Sleeve Gastrectomy (LSG), which has shown comparable weight loss and diabetes resolution with fewer nutritional deficiencies. 2) Duodenal Switch, which combines restrictive and malabsorptive elements and has demonstrated significant weight loss and diabetes improvement. 3) Endoscopic procedures like Intragastric Balloon Systems, which are less invasive and promote weight loss by inducing satiety. 4) Electrical stimulation (vagal blockade) systems, which suppress neural communication between the brain and stomach to promote weight loss.

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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

No Placebo-Only Group

Summary

This trial compares weight loss from surgery and dieting in obese people, some with diabetes. Both methods aim to improve how the body processes sugar and overall health by significantly reducing body weight.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in hepatic insulin sensitivity

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include pharmacological therapies like GLP-1 receptor agonists, lifestyle interventions such as low-calorie diets, and surgical options like Roux-en-Y Gastric Bypass (RYGB). GLP-1 receptor agonists improve glucose control, promote weight loss, and reduce food intake by slowing gastric emptying and acting on the central nervous system. Low-calorie diets induce weight loss by reducing caloric intake, which improves insulin sensitivity and glycemic control. RYGB surgery alters the digestive system to reduce food intake and absorption, leading to significant weight loss and improved glucose homeostasis. These mechanisms are crucial for T2DM patients as they address both hyperglycemia and obesity, which are central to the disease's progression and complications.

Revisiting the concept of incretin and enteroendocrine L-cells as type 2 diabetes mellitus treatment.The Impact of Bariatric Surgery on Type 2 Diabetes Mellitus and the Management of Hypoglycemic Events.Gut hormones and the brain.