Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects

181978

The investigators will recruit obese subjects with pre-diabetes or type 2 diabetes for the proposed clinical study for 5 visits. After informed written consent is obtained, subjects will be admitted to the Clinical Research Center, and will undergo upper endoscopic injection of Botox into the duodenal wall. The investigators anticipate that injections of Botox into the duodenal wall will result in significant weight loss and improvements in glucose tolerance and duodenal nutrient sensitivity. Subjects will be studied over a period of 6 months. Subjects will be asked to complete 5 study visits: On the first visit, each subject will undergo an oral glucose tolerance test. At visit 2, subjects will undergo an esophagogastroduodenoscopy procedure for the delivery of Botox to the duodenal wall. Visits 3-5 will be made 1, 3, and 6 months later. On every study visit, body weight and body composition will be recorded and oral glucose tolerance test will be performed. Nutrient sensing test will be performed at visits 1 and 3.

2021-04-29

2022-02-11

2022-02-11

Terminated

Early phase I

4

Inclusion Criteria: 1. Age = 18-65 2. BMI ≥ 30 kg/m2 3. Having established diagnosis of Type 2 diabetes or pre-diabetes Exclusion Criteria: 1. Patients on insulin therapy 2. Endoscopy within the past 6 weeks 3. Prior bariatric surgery 4. Anti-obesity drugs 5. Serum Creatinine \> 1.5 mg/dL 6. Hepatic enzyme elevations \> 2x the upper limits of normal 7. Current use of warfarin 8. Abnormal ECG 9. Positive pregnancy test for female subjects in the child bearing age 10. Pre-existing cardiovascular disease (heart attack in the past 3 months, cardiac stenting, heart valve disorders) 11. Prior surgery on the alimentary tract 12. Gastroparesis 13. Inflammatory bowel disease 14. Liver failure

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2023-02-28