Gastric Electrical Stimulation (GES) for the Treatment of Obesity

Once adjudicated by the Adverse Events Advisory Committee (AEAC), all adverse events recorded during the study were tabulated and summarized by seriousness, intensity, and related. Device performance and use conditions where characterized by collecting data on amplitude settings and lead impedance recorded during device interrogations and conducted at each clinic visits. The data will be tabulated and summarized using descriptive statistics, but no hypotheses tests were pre-specified

In-clinic sensory testing and telephone follow-up were collected during Amplitude Titration phase and will be summarized. No formal hypothesis testing were pre-specified. Fourt separate visits were conducted approximately weekly during the titration phase. The testing procedure was expected to be repeated twice during each visits; once in a fasted state and once in a fed state. Subjects were asked to rate exposure sensitive from 0 (none) to 5 (intense)

During the two GI function visits subjects completed the same set of acute tests on two separate days, once with GES On and once with GES Off. Treatment ordering was randomly assigned in a balanced fashion. Each testing visit was preceded by a one week GES Off washout period. The gastric emptying half time outcomes in the acute cross-over experiment will be analyzed using the repeated measures regression with fixed subject and test-day effects, with the model-based t-test for the difference in the marginal means of T1/2 across treatments being used for statistical inference.

Antral motility index outcomes in the acute cross-over experiment were analyzed using the repeated measures regression with fixed subject and test-day effects. The model-based t-test for the difference in the marginal means of the MI values across treatments will be used for statistical inference.

Blood samples were collected in conjunction with the gastric emptying test meals to explore whether GES alters plasma levels of gut peptides involved in regulating food intake and body weight, including GLP-1, PP, and CCK.

During the GI function tests in the acute-cross over experiments subjects were fed a macaroni and cheese meal in a controlled setting. the meal was given at each GI function visit once with GES On and once with GES Off. The caloric intake was measured during the visit to determine whether the GES On would reduce meal intake.

The values of physiological measures, psychometric assessment questionnaire scores and changes in these values from the Screening visit baseline will be summarized by visit using descriptive statistics. Medications will be categorized by their primary indications for use, and the proportion of subjects taking medications in each category and the mean number of medications in each category per subject will be calculated at each visit and plotted over time. No formal hypothesis testing will be conducted.