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Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes

Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05984459
Enrollment
39
Registered
2023-08-09
Start date
2023-01-30
Completion date
2023-10-02
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Type 2 Diabetes Mellitus

Keywords

Very low-calorie ketogenic diet, VLCKD, Type 2 diabetes, Overweight, Obesity

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.

Interventions

DIETARY_SUPPLEMENTVLCKD

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

Sponsors

Trialance SCCL
CollaboratorINDUSTRY
Cabinet Medical
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes remission24 monthsMeasured as HbA1c (%)

Secondary

MeasureTime frameDescription
Change in body fat24 monthsMeasuared in percentage (%)
Change in visceral fat24 monthsMeasuared in percentage (%)
Change in waist circumference24 monthsMeasured in percentage (%)
Change in body weight24 monthsMeasured as kilograms (kg)
Number of type 2 diabetes remissions24 monthsMeasured as count of participants
Decreases in poglycemic drug treatments24 monthsMeasured as changes in the number of diabetes treatments
Change in Body Mass Index (BMI)24 monthsMeasured in kilogram per square meter (kg/m\^2)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026