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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05984459
• Other study ID #: FMH Endocrinol and Diabetol
• Status: Completed
• Start date: January 30, 2023
• Est. completion date: October 2, 2023

Study information

• Verified date: August 2023
• Source: Cabinet Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Overweight and Obesity
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• VLCKD
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

Locations

Country	Name	City	State
Switzerland	Dr. Daniela Sofra	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Cabinet Medical	Trialance SCCL

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes remission	Measured as HbA1c (%)	24 months
Secondary	Change in body weight	Measured as kilograms (kg)	24 months
Secondary	Change in body fat	Measuared in percentage (%)	24 months
Secondary	Change in visceral fat	Measuared in percentage (%)	24 months
Secondary	Change in waist circumference	Measured in percentage (%)	24 months
Secondary	Change in Body Mass Index (BMI)	Measured in kilogram per square meter (kg/m^2)	24 months
Secondary	Number of type 2 diabetes remissions	Measured as count of participants	24 months
Secondary	Decreases in poglycemic drug treatments	Measured as changes in the number of diabetes treatments	24 months