NCT05896358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 12, 2023

Last Update Submit

June 14, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight change

    body mass change (kg) within and between groups

    at baseline and right after the dietary intervention (8 weeks)

Secondary Outcomes (10)

  • 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)

  • +5 more secondary outcomes

Study Arms (2)

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

ketogenic dietBEHAVIORAL

a low calorie ketogenic diet

Bariatric naivePost Bariatric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • obesity (BMI ≥ 30 Kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome

Roma, 00161, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, stool

MeSH Terms

Conditions

Obesity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • lucio gnessi

    sapienza università di roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 9, 2023

Study Start

March 1, 2023

Primary Completion

June 30, 2023

Study Completion

January 30, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

IT(1)