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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: VLCKD

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1003
    • Dr. Daniela Sofra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A patient cohort with overweight and type 2 diabetes.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes remission	Measured as HbA1c (%)	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cabinet Medical
• Collaborators: Trialance SCCL

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Type 2 diabetes; Overweight; VLCKD; Very low-calorie ketogenic diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: FMH Endocrinol and Diabetol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No