NCT05896358|Unknown
Dietary Treatment for Post Bariatric Weight Regain
WRKD
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WRKD
Sponsor study identifier
observational
30
1 country
1
Study Start
March 1, 2023
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2023
Actual (reported)May 12, 2023
Actual (reported)June 9, 2023
Actual (reported)June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
weight change
body mass change (kg) within and between groups
at baseline and right after the dietary intervention (8 weeks)
body fat change
at baseline and right after the dietary intervention (8 weeks)
muscle mass change
at baseline and right after the dietary intervention (8 weeks)
waist circumference change
at baseline and right after the dietary intervention (8 weeks)
mean blood pressure change
at baseline and right after the dietary intervention (8 weeks)
glucose concentration change
at baseline and right after the dietary intervention (8 weeks)
patients with obesity who have not undergone bariatric surgery in the past
patients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss
a low calorie ketogenic diet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pre bariatric treatment arm will be composed of: -individuals with no history of bariatric surgery Post bariatric treatment arm will be composed of: * individuals with previous metabolic surgery (RYGB or Sleeve gastrectomy) and * excess WL \< 50% at 18 months after surgery (IWL) or * clinically relevant WR after satisfactory WL
Sapienza University of Rome
Roma, 00161, Italy
plasma, stool
lucio gnessi
sapienza università di roma
First Submitted
May 12, 2023
First Posted
June 9, 2023
Study Start
March 1, 2023
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living With Obesity
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 18, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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