Dietary Treatment for Post Bariatric Weight Regain | NCT05896358

Studies
Dietary Treatment for Post Bariatric Weight Regain

NCT05896358

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Obesity

Interventions

ketogenic diet

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jan 30, 2024Estimated

First Submitted Date

May 12, 2023

First Submission Date that Met QC Criteria

May 29, 2023

First Posted Date

Jun 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Metabolic surgery is, to date, the strategy for the treatment of obesity with the greatest long-term efficacy. However, especially in those lost to surgical and nutritional follow-up, weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. In particular, depending on the type of surgery considered, it has been observed that up to 40% of subjects undergoing surgery report a WR long term, where data on IWL are still insufficient to draw well-defined estimates. WR and IWL are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed, with increased risk of complications and little effect.

The ketogenic diet is one of the pivotal dietary therapies for the treatment of obesity, with excellent evidence in terms of weight loss and improvement in complications of excess weight. Very little data is available regarding its application on post bariatric patients: Correa and colleagues reported in a retrospective case series the efficacy and safety of a very low calorie ketogenic diet (VLCKD) in 11 patients with IWL or WR after gastric bypass, reporting a good safety profile, good tolerability, and an average weight loss of 9 kg in 2 months of therapy. Although promising, the data in the literature are extremely scarce, and therefore ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL.

The objective of this study is to test whether the application of a ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric naive		patients with obesity who have not undergone bariatric surgery in the past	Behavioral: ketogenic diet
Post Bariatric		patients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss	Behavioral: ketogenic diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ketogenic diet	Behavioral	a low calorie ketogenic diet	Bariatric naive Post Bariatric

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight change	body mass change (kg) within and between groups	at baseline and right after the dietary intervention (8 weeks)

Secondary Outcomes

Measure	Description	Time Frame
body fat change	body fat change (kg) within and between groups	at baseline and right after the dietary intervention (8 weeks)
muscle mass change	lean mass change (kg) within and between groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-obesity (BMI ≥ 30 Kg/m2)

Exclusion Criteria:

Type 1 diabetes mellitus
Renal failure (GFR<60)
Liver failure (decompensated cirrhosis)
Congenital metabolic diseases
Pregnancy
lactation
Major psychiatric disorder
Alcoholism
drug addiction
patients who are not self-sufficient and without adequate family and social support

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
lucio gnessi	sapienza università di roma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sapienza University of Rome		Roma		00161	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055423	Diet, Ketogenic

Ancestor Terms

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided