The Effect of Extended Use of the Epitomee Capsule on BodyWeight in subjects with Overweight and Obesity with and without Prediabetes
This is an interventional, open label, single arm extension study to assess the long-term safety and efficacy of the Epitomee Capsule in subjects who completed a 24-week treatment period with the Epitomee-Capsule and experienced at least 3% weight loss during that period. All participating subjects will receive the Epitomee capsule arm in combination with lifestyle intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Epitomee Capsule combined with lifestyle counseling.
University of Alabama Department of Nutrition Sciences
Birmingham, Alabama, United States
Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119
Winston-Salem, North Carolina, United States
Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,
Philadelphia, Pennsylvania, United States
Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule
Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule during the course of the study
Time frame: 24 weeks
Change in percent weight loss
Change in percent weight loss between baseline weight of the Epitomee core study and week 24 of the extension study
Time frame: 24 weeks
Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule.
Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule during the course of the study
Time frame: 24 weeks
Proportion of subjects who maintain loss of 3% or more of their body weight
Proportion of subjects who maintain loss of 3% or more of their body weight from baseline of the Epitomee core study to week 24 of the extension study
Time frame: 24 weeks
Proportion of subjects who lose or maintain loss of 5 % or more of their body weight
Proportion of subjects who lose or maintain loss of 5 % or more of their body weight from baseline of the Epitomee core study to week 24 of the extension study
Time frame: 24 weeks
Change in plasma fasting glucose
Change in plasma fasting glucose from baseline of the Epitomee core study to week 24 of the extension study
Time frame: 24 weeks
Change in glycemic status (Normoglycemia, Prediabetes and Diabetes)
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Change in glycemic status (Normoglycemia, Prediabetes and Diabetes) between the Epitomee core study baseline and week 24 of the extension study
Time frame: 24 weeks
Changes in BMI reduction
Changes in BMI reduction between baseline BMI in the Epitomee core study and week 24 of the extension study.
Time frame: 24 weeks