ObesityWRKDNCT05896358
Dietary Treatment for Post Bariatric Weight Regain
An observational study of Obesity, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ketogenic diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- -obesity (BMI ≥ 30 Kg/m2)
Who cannot join
- Type 1 diabetes mellitus
- Renal failure (GFR<60)
- Liver failure (decompensated cirrhosis)
- Congenital metabolic diseases
- Pregnancy
- lactation
Show all 10Show fewer
- Major psychiatric disorder
- Alcoholism
- drug addiction
- patients who are not self-sufficient and without adequate family and social support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- ketogenic diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketogenic dietBehavioural
a low calorie ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Bariatric naive | patients with obesity who have not undergone bariatric surgery in the past Receives: 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 Receives: Behavioral: ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
body mass change (kg) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
Secondary outcomes (10)
body fat change
body fat change (kg) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
muscle mass change
lean mass change (kg) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
waist circumference change
waist circumference change (cm) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
mean blood pressure change
mean blood pressure change (mmHg) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
glucose concentration change
glucose change (mg/dL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
insulin concentration change
insulin change (UI/mL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
uric acid concentration change
uric acid change (mg/dL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
creatinine concentration change
creatinine change (mg/dL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
cholesterol concentration change
cholesterol change (mg/dL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
triglycerides concentration change
triglycerides change (mg/dL) within and between groups
Measured: at baseline and right after the dietary intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Mar 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucio Gnessi, University of Roma La Sapienza
- Investigators
- lucio gnessi, Principal investigator, sapienza università di roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896358
- Sponsor's protocol ID
- 2023KDWR
- Acronym
- WRKD
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD
- ClinicalTrials.gov ID
- NCT05896358
- Acronym / sponsor ID
- WRKD / 2023KDWR
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric naive | – | Behavioral: ketogenic dietpatients with obesity who have not undergone bariatric surgery in the past |
| Post Bariatric | – | Behavioral: ketogenic dietpatients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- -obesity (BMI ≥ 30 Kg/m2)
Key exclusion criteria (10 listed)
- Type 1 diabetes mellitus
- Renal failure (GFR<60)
- Liver failure (decompensated cirrhosis)
- Congenital metabolic diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketogenic dieta low calorie ketogenic diet | Behavioural | Bariatric naive, Post Bariatric |
Primary outcome
weight change
Time frame: at baseline and right after the dietary intervention (8 weeks)
body mass change (kg) within and between groups
10 secondary outcomes
body fat change
Time frame: at baseline and right after the dietary intervention (8 weeks)
muscle mass change
Time frame: at baseline and right after the dietary intervention (8 weeks)
waist circumference change
Time frame: at baseline and right after the dietary intervention (8 weeks)
mean blood pressure change
Time frame: at baseline and right after the dietary intervention (8 weeks)
glucose concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
insulin concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
uric acid concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
creatinine concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
cholesterol concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
triglycerides concentration change
Time frame: at baseline and right after the dietary intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lucio gnessi principal investigator
sapienza università di roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: at baseline and right after the dietary intervention (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.