Comparison of Weight Loss and Nutritional Deficiency After One Anastomosis Gastric Bypass at 150, 170, and 200 cm From the Duodenojejunal Junction

Not Applicable

Completed

• Conditions: Obesity; Nutritional Deficiency; Type 2 Diabetes Mellitus (T2DM); Bariatric Surgery (Gastric Bypass)

• Registration Number: NCT06664099
• Lead Sponsor: Cairo University

Brief Summary

This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. One Anastomosis Gastric Bypass is a type of bariatric surgery that combines aspects of a gastric sleeve and a traditional gastric bypass, aiming to achieve effective weight loss and improvement in health conditions associated with obesity.

The study will include 60 adult patients between 18 and 60 years old with a Body Mass Index of 35 kilograms per square meter or greater, or a Body Mass Index of 30 kilograms per square meter or greater with obesity-related health conditions, who have not achieved adequate results through diet, exercise, or medication. Participants will be randomly assigned to one of three groups, each undergoing One Anastomosis Gastric Bypass with a different limb length from the duodenojejunal junction: 150 centimeters, 170 centimeters, or 200 centimeters.

The primary outcomes measured will include the percentage of total weight loss, the percentage of excess weight loss, and postoperative nutritional status, particularly in terms of levels of albumin, calcium, iron, and ferritin. Secondary outcomes will assess the remission of health conditions related to obesity, including high blood pressure and type 2 diabetes mellitus, as well as patient quality of life following surgery.

By examining the impact of One Anastomosis Gastric Bypass at varying limb lengths on weight loss and nutritional deficiencies, this study aims to identify an optimal surgical approach that balances effective weight management and minimizes the risk of postoperative malnutrition. The findings will inform surgical decision-making and postoperative management strategies for individuals undergoing One Anastomosis Gastric Bypass.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Study First Posted: 2024-10-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults aged 18 to 60 years.
• Body Mass Index (BMI) of 35 kg/m² or higher, or BMI of 30 kg/m² or higher with significant obesity-related comorbidities.
• Failed adequate conservative management (diet, exercise, and/or medication) for at least 6 months.
• Demonstrated psychological stability and motivation for surgery.
• Acceptance of the surgical risks associated with bariatric procedures.

Exclusion Criteria

• Prior abdominal exploratory surgery.
• Previous bariatric surgery.
• Pre-existing significant nutritional deficiencies.
• Pregnancy or current lactation.
• Severe, long-standing cardiac or pulmonary disease or other serious systemic illnesses.
• Active substance or alcohol abuse.
• Active gastric ulcer disease.
• Psychological instability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Total Weight Loss	12 months post-surgery	This outcome measures the percentage of total weight loss achieved by participants one year after undergoing One Anastomosis Gastric Bypass at specified lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Total weight loss is calculated as the percentage change in body weight from the initial weight measured preoperatively. This measure provides insight into the effectiveness of different bypass lengths in achieving weight loss in patients with obesity.
Incidence of Nutritional Deficiency in Albumin	12 months post-surgery	This outcome measures the incidence of albumin deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Albumin deficiency is defined as serum albumin levels below 3.0 g/dL, indicating a risk of protein malnutrition. This outcome will help assess the nutritional impact of different bypass lengths.
Incidence of Nutritional Deficiency in Calcium	12 months post-surgery	This outcome measures the incidence of calcium deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Calcium deficiency is defined as serum calcium levels below 8.5 mg/dL, which can indicate a risk of bone health complications and overall nutritional deficiency. This measure will evaluate the impact of different bypass lengths on calcium levels.
Incidence of Nutritional Deficiency in Iron	12 months post-surgery	This outcome measures the incidence of iron deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Iron deficiency is defined as serum iron levels below 50 µg/dL, indicating a risk of anemia and associated health complications. This outcome will help assess the influence of different bypass lengths on iron absorption and nutritional status.

Secondary Outcome Measures

Name	Time	Method
Remission Rate of Type 2 Diabetes Mellitus	12 months post-surgery	This outcome measures the rate of remission of type 2 diabetes mellitus in participants one year after undergoing One Anastomosis Gastric Bypass surgery at different limb lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Remission of diabetes is defined as achieving a fasting blood glucose level below 126 mg/dL and an HbA1c level below 6.5% without the use of antidiabetic medication. This outcome will evaluate the impact of bypass length on diabetes remission.
Improvement in Hypertension	12 months post-surgery	This outcome measures the improvement rate of hypertension among participants one year after undergoing One Anastomosis Gastric Bypass at varying lengths from the duodenojejunal junction. Improvement is defined as maintaining blood pressure below 135/85 mm Hg without the use of antihypertensive medications. This outcome will help assess the effectiveness of the surgery at different limb lengths in managing blood pressure levels.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt