Type 2 Diabetes MellitusNCT05984459
Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
An observational study of Type 2 Diabetes Mellitus and Overweight and Obesity, run by Cabinet Medical at 1 site in Switzerland.
Trial summary
There is a strong correlation between being overweight, specifically with abdominal fat, and type 2 diabetes mellitus (T2DM). Recent scientific literature has highlighted the connection between significant weight loss, specifically 15% or more of body weight, and its positive impact on body composition and glycemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight and Obesity
- What is being tested?
- VLCKD
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jan 2023to 2 Oct 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A patient cohort with overweight and type 2 diabetes.
Who may be able to join
- Have a diagnosis of type 2 diabetes
- Being overweight (BMI > 25 kg/m^2) or obesity (BMI > 29.9 kg/m^2)
- Have wished to engage in a weight loss program according to the PnK® method
- Have accepted and signed the consent for the use of data
Who cannot join
- Pregnancy or lactation
- Type 1 diabetes
- Eating disorders
- Psychiatric disorders
- Have any contraindication for doing the active or ketogenic phase
Trial locations and contacts
1 site in 1 country.
About this study
There is a strong correlation between being overweight, specifically with abdominal fat, and type 2 diabetes mellitus (T2DM). Recent scientific literature has highlighted the connection between significant weight loss, specifically 15% or more of body weight, and its positive impact on body composition and glycemic profiles. In this study, the focus is on very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess weight and improving diabetes. Current research is transforming the understanding of T2DM, demonstrating that effective and timely interventions can lead to diabetes remission, including a partial recovery of insulin secretion and function.
However, the daily life of a diabetic patient in a clinical setting may not always mirror that of a patient participating in a study, who receives planned follow-up visits and close supervision. To address this discrepancy, this study aims to analyze a cohort of patient records with T2DM and overweight who have adopted a VLCKD, specifically through the PnK® Method, in a private diabetology practice. The goal is to assess the impact of VLCKD on glycemic control in real-life scenarios.
Read the detailed description
The investigator wishes to carry out an observational, retrospective, uncontrolled, monocentric analysis on a group of patients with overweight and type 2 diabetes mellitus (T2DM).
The analysis will focus on the observation of the evolution of anthropometric and clinical parameters, such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication.
The data collected and analyzed will correspond to 4 moments:
- T0, at the start of treatment.
- T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks.
- T2, after 6-9 months of support and individualized therapeutic education for a new lifestyle.
- T3, after 18-24 months of usual follow-up with 1 visit every 3 to 6 months.
The population included in the analysis consists of adults with T2DM, with a BMI greater than 25 kg/m2, followed in a diabetology office. This constitutes a form of selection of the population because people with more social, economic, linguistic difficulties, more complex pathologies will be better taken care of in a hospital environment.
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Being tested
- VLCKD
- Keywords
- Very low-calorie ketogenic diet, VLCKD, Type 2 diabetes, Overweight, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLCKDDietary supplement
The analysis will focus on the observation of the evolution of anthropometric and clinical parameters,such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication between patients who accept VLCKD method
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes remission
Measured as HbA1c (%)
Measured: 24 months
Secondary outcomes (7)
Change in body weight
Measured as kilograms (kg)
Measured: 24 months
Change in body fat
Measuared in percentage (%)
Measured: 24 months
Change in visceral fat
Measuared in percentage (%)
Measured: 24 months
Change in waist circumference
Measured in percentage (%)
Measured: 24 months
Change in Body Mass Index (BMI)
Measured in kilogram per square meter (kg/m^2)
Measured: 24 months
Number of type 2 diabetes remissions
Measured as count of participants
Measured: 24 months
Decreases in poglycemic drug treatments
Measured as changes in the number of diabetes treatments
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start30 Jan 2023
- Primary completion20 Jul 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cabinet Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Trialance SCCL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984459
- Sponsor's protocol ID
- FMH Endocrinol and Diabetol
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
- ClinicalTrials.gov ID
- NCT05984459
- Acronym / sponsor ID
- FMH Endocrinol and Diabetol
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Keywords
- Very low-calorie ketogenic diet, VLCKD, Type 2 diabetes, Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cabinet MedicalUniversity, hospital or other
- Collaborators
- Trialance SCCL
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 9 Aug 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.
There is a strong correlation between being overweight, specifically with abdominal fat, and type 2 diabetes mellitus (T2DM). Recent scientific literature has highlighted the connection between significant weight loss, specifically 15% or more of body weight, and its positive impact on body composition and glycemic profiles. In this study, the focus is on very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess weight and improving diabetes. Current research is transforming the understanding of T2DM, demonstrating that effective and timely interventions can lead to diabetes remission, including a partial recovery of insulin secretion and function.
However, the daily life of a diabetic patient in a clinical setting may not always mirror that of a patient participating in a study, who receives planned follow-up visits and close supervision. To address this discrepancy, this study aims to analyze a cohort of patient records with T2DM and overweight who have adopted a VLCKD, specifically through the PnK® Method, in a private diabetology practice. The goal is to assess the impact of VLCKD on glycemic control in real-life scenarios.
Detailed description
The investigator wishes to carry out an observational, retrospective, uncontrolled, monocentric analysis on a group of patients with overweight and type 2 diabetes mellitus (T2DM).
The analysis will focus on the observation of the evolution of anthropometric and clinical parameters, such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication.
The data collected and analyzed will correspond to 4 moments:
- T0, at the start of treatment.
- T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks.
- T2, after 6-9 months of support and individualized therapeutic education for a new lifestyle.
- T3, after 18-24 months of usual follow-up with 1 visit every 3 to 6 months.
The population included in the analysis consists of adults with T2DM, with a BMI greater than 25 kg/m2, followed in a diabetology office. This constitutes a form of selection of the population because people with more social, economic, linguistic difficulties, more complex pathologies will be better taken care of in a hospital environment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient cohort with overweight and type 2 diabetes.
Key inclusion criteria (4 listed)
- Have a diagnosis of type 2 diabetes
- Being overweight (BMI > 25 kg/m^2) or obesity (BMI > 29.9 kg/m^2)
- Have wished to engage in a weight loss program according to the PnK® method
- Have accepted and signed the consent for the use of data
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Type 1 diabetes
- Eating disorders
- Psychiatric disorders
- Have any contraindication for doing the active or ketogenic phase
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 |
|---|---|---|
| VLCKDThe analysis will focus on the observation of the evolution of anthropometric and clinical parameters,such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication between patients who accept VLCKD method | Dietary supplement | – |
Primary outcome
Diabetes remission
Time frame: 24 months
Measured as HbA1c (%)
7 secondary outcomes
Change in body weight
Time frame: 24 months
Change in body fat
Time frame: 24 months
Change in visceral fat
Time frame: 24 months
Change in waist circumference
Time frame: 24 months
Change in Body Mass Index (BMI)
Time frame: 24 months
Number of type 2 diabetes remissions
Time frame: 24 months
Decreases in poglycemic drug treatments
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 Diabetes Mellitus and Overweight and Obesity, run by Cabinet Medical at 1 site in Switzerland.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Nov 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diabetes remission (time frame: 24 months). 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 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.