PWS: Age range 18-65; genetically confirmed PWS Obese: Age range 18-65; BMI>30 Lean: Age range 18-65; BMI<25 4.2 EXCLUSION CRITERIA PWS: Uncontrolled access to food in current living situation; history of psychological illness within previous 12 months; pregnant women. Obese: unstable body weight within previous 3 months (+/- 2kg or greater); pregnant women. Lean: unstable body weight within previous 3 months (+/- 2kg or greater); pregnant women. 5. STUDY OUTLINE 5.1 STUDY FLOW CHART (FIGURE 1) 5.2 INVESTIGATION PLAN Table 1: Procedures performed at the Garvan Clinical Research Facility during the study. Study visits: Lean and obese control subjects Visit 1 – Screening and enrolment: After initial contact by phone in response to newspaper advertisement, control subjects will undergo screening at the Garvan Institute Clinical Research Facility. A clinical assessment will be performed and, if suitable for the study and willing to participate, subjects will give informed consent and enter the study. Visit 2 – Gastric scintigraphy study: Participants will fast from 10:00pm the night before the study and, upon arrival at the Garvan Institute Clinical Research Facility at 8:00am on the study day, height, weight and waist and hip circumference will be measured, and fasting blood samples will be drawn. Participants will be taken across the road to St Vincent’s Hospital where they will undergo a gastric scintigraphy study, which involves insertion of an intravenous cannula, eating a labelled breakfast and having blood samples collected at regular intervals. After completion of the scintigraphy study, participants will have a DXA scan at St Vincent’s Hospital to quantify lean mass and fat mass.
PWS: Age range 18-65; genetically confirmed PWS Obese: Age range 18-65; BMI>30 Lean: Age range 18-65; BMI<25 4.2 EXCLUSION CRITERIA PWS: Uncontrolled access to food in current living situation; history of psychological illness within previous 12 months; pregnant women. Obese: unstable body weight within previous 3 months (+/- 2kg or greater); pregnant women. Lean: unstable body weight within previous 3 months (+/- 2kg or greater); pregnant women. 5. STUDY OUTLINE 5.1 STUDY FLOW CHART (FIGURE 1) 5.2 INVESTIGATION PLAN Table 1: Procedures performed at the Garvan Clinical Research Facility during the study. Study visits: Lean and obese control subjects Visit 1 – Screening and enrolment: After initial contact by phone in response to newspaper advertisement, control subjects will undergo screening at the Garvan Institute Clinical Research Facility. A clinical assessment will be performed and, if suitable for the study and willing to participate, subjects will give informed consent and enter the study. Visit 2 – Gastric scintigraphy study: Participants will fast from 10:00pm the night before the study and, upon arrival at the Garvan Institute Clinical Research Facility at 8:00am on the study day, height, weight and waist and hip circumference will be measured, and fasting blood samples will be drawn. Participants will be taken across the road to St Vincent’s Hospital where they will undergo a gastric scintigraphy study, which involves insertion of an intravenous cannula, eating a breakfast and having blood samples collected at regular intervals. After completion of the scintigraphy study, participants will have a DXA scan at St Vincent’s Hospital to quantify lean mass and fat mass. labelled
370723-ENGAGE_Protocol_v2.docx