Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
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.