Clinical trial NCT05984459: Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
Official title: Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Overweight and Obesity
Keywords: Very low-calorie ketogenic diet
VLCKD
Type 2 diabetes
Overweight
Obesity
Lead sponsor: Cabinet Medical
Sponsor class: OTHER
Collaborators: name: Trialance SCCL
First posted: 2023-08-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient cohort with overweight and type 2 diabetes.

Brief 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 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:

1. T0, at the start of treatment.
2. T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks.
3. T2, after 6-9 months of support and individualized therapeutic education for a new lifestyle.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Eating disorders
* Psychiatric disorders
* Have any contraindication for doing the active or ketogenic phase

Primary outcomes:
measure: Diabetes remission
timeFrame: 24 months
Secondary outcomes:
measure: Change in body weight
timeFrame: 24 months
measure: Change in body fat
timeFrame: 24 months
measure: Change in visceral fat
timeFrame: 24 months
measure: Change in waist circumference
timeFrame: 24 months
measure: Change in Body Mass Index (BMI)
timeFrame: 24 months
measure: Number of type 2 diabetes remissions
timeFrame: 24 months
measure: Decreases in poglycemic drug treatments
timeFrame: 24 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dr. Daniela Sofra
Study officials:
References: