Clinical trials: Metabolic Surgery
Hypoglycemia
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
- Trial name
- XOMA 358 (NCT02772718)
- Testing
- XOMA 358 single dose level A, XOMA 358 single dose level B, XOMA 358 single dose level C
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- XOMA (US) LLC
Obesity
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead…
- Trial name
- NCT03147456
- Testing
- (Cubitan Protein, Nutricia, Netherlands)., (preOp, Nutricia, Netherlands).
- Where
- Qatar
- Volunteers
- 80 people
- Sponsor
- Hamad Medical Corporation
Gallstones
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in…
- Trial name
- NCT02325492
- Testing
- Aramchol, Ultrasound
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Galmed Pharmaceuticals Ltd
Obesity, Overweight
ORBERA365 Post-Marketing Clinical Follow-up Study
A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight…
- Trial name
- NCT04362774
- Testing
- ORBERA365
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Apollo Endosurgery, Inc.
Post-bariatric Hypoglycemia
An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program.
- Trial name
- NCT07582874
- Testing
- Avexitide
- Where
- 4 sites in United States
- Sponsor
- Amylyx Pharmaceuticals Inc.
Obesity
Noom Coach for Bariatric Health
Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however…
- Trial name
- NCT03887078
- Testing
- Noom Coach for Bariatric Health
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Noom Inc.
Pain, Postoperative, Postoperative Pain
Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.
The purpose of this study is to determine the effectiveness of aerosolized pain medication (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass surgery.
- Conditions
- Pain, Postoperative, Postoperative Pain, Abdominal Pain, Obesity
- Trial name
- NCT00286286
- Testing
- Intraperitoneal Aerosolization System, IntraMyst
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Northgate Technologies
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes
Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus
- Trial name
- NCT00596973
- Testing
- Surgical Treatment
- Where
- United States
- Sponsor
- Medtronic - MITG
Diabetes, Obesity
Prospective Metabolic Surgery in T2DM Chinese Subjects
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.
- Trial name
- NCT02217943
- Testing
- Roux-en-Y gastric bypass, Sleeve gastrectomy
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon Endo-Surgery
Mucopolysaccharidosis (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
Enteral Nutrition Regimen Prior to Surgery
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
- Trial name
- NCT00662376
- Testing
- PreOP Booster (oral nutritional supplement, food for special medical purposes)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Obesity, Roux-en-Y Gastric Bypass
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted…
- Trial name
- SIRIUS (NCT04543526)
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- 2 sites in Belgium
- Sponsor
- Duomed
Obesity, Bariatric Surgery
Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months.
- Trial name
- Refill (NCT02440087)
- Testing
- Refill Bypass
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Refill France
Post Bariatric Hypoglycemia
Avexitide for Treatment of Post-Bariatric Hypoglycemia
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB).
- Trial name
- LUCIDITY (NCT06747468)
- Testing
- Avexitide
- Where
- 21 sites in United States
- Volunteers
- 75 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Morbid Obesity
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
- Trial name
- NCT01077193
- Testing
- Gastric Plication
- Where
- 3 sites in United States, Czechia
- Volunteers
- 44 people
- Sponsor
- Ethicon Endo-Surgery
Nutritional Deficiency
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by…
- Trial name
- NCT00950976
- Testing
- citrulline, Lemonade
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Diabetes
Neuroendocrine Brake for Type 2 Diabetes Mellitus
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
- Trial name
- NCT00450710
- Testing
- ileal interposition with a sleeve gastrectomy
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Medtronic - MITG
Critical Illness
Feasibility of Tight Blood Glucose Control With the Space TGC System in Surgical ICU Patients
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care.
- Trial name
- DELIOS 03 (NCT01146847)
- Testing
- Space TGC
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- B. Braun Melsungen AG
Obesity
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
- Trial name
- RESULTS (NCT00566943)
- Testing
- PSD Veritas Collagen Matrix, Roux-en-Y gastric by-pass surgery with no buttress
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation