Obesity Clinical Trial
Official title:
A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Verified date | June 2024 |
Source | GI Windows, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | November 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 19-65 years at screening - Body mass index (BMI) =35 and =50 - T2DM diagnosis =6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c = 6.5% but < 10.0% at time of enrollment. - HbA1c must be stable over a 3-month period. - Weight stable over 3-month period - Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled - Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years - If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period - Able to understand and sign informed consent documents. Exclusion Criteria: - Known or suspected allergy to nickel or titanium or nitinol - Type 1 diabetes or poorly controlled type 2 diabetes - Use of injectable insulin - Any documented conditions for which endoscopy would be contraindicated - Contraindication to general anesthesia - History of chronic gastrointestinal disease - Congenial or acquired anomalies of the GI tract - Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. - Uncontrolled hypertension - Pre-existing severe comorbid cardio-respiratory disease - History of chronic gastrointestinal disease - Specific genetic or hormonal cause of obesity - Recent tobacco/nicotine product cessation (within 3 months prior) |
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Université Laval | Quebec City | Quebec |
Lead Sponsor | Collaborator |
---|---|
GI Windows, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight Loss | Weight loss measured as a percent of total body weight (TBW) | 12 months | |
Secondary | Percent Responders | Percent responders; i.e. percent of subjects losing at least 10% TBW | 12 months | |
Secondary | Excess Weight Loss Measures | Excess weight loss (EWL) | 12 months | |
Secondary | Absolute Weight Loss Measures | Absolute weight loss | 12 months | |
Secondary | BMI - Weight Loss Measures | Change in BMI | 12 months | |
Secondary | Fasting Glucose | Mean change in fasting glucose | 12 months | |
Secondary | Hemoglobin A1c | Mean change in Hemoglobin A1c | 12 months | |
Secondary | Diabetes Remission and/or Improvements | Proportion of subjects experiencing diabetes remission and/or improvements | 12 months | |
Secondary | Diabetes Medication Dosage and Frequency Changes | Mean change in the dosage and frequency of diabetes medications from baseline | 12 months | |
Secondary | Serum Lipids | Mean change in serum lipids | 12 months | |
Secondary | Blood Pressure Changes | Mean percent change in systolic/diastolic blood pressure | 12 months | |
Secondary | Liver Changes using Fibroscan | Change in Controlled Attenuation Parameter (CAP) Scores from baseline | 12 months | |
Secondary | Nutritional Status | Nutritional Status: changes in pre-albumin levels | 12 months | |
Secondary | Albumin - Nutritional Status | Nutritional Status: changes in albumin levels | 12 months |
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