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

NCT05984459 | Completed

• 1 other identifier: FMH Endocrinol and Diabetol
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diabetes remission

  Measured as HbA1c (%)

  24 months

Secondary Outcomes (7)

• Change in body weight

  24 months

• Change in body fat

  24 months

• Change in visceral fat

  24 months

• Change in waist circumference

  24 months

• Change in Body Mass Index (BMI)

  24 months

Interventions

VLCKD DIETARY_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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A patient cohort with overweight and type 2 diabetes.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cabinet Medical: lead
• Trialance SCCL: collaborator

Study Sites (1)

Dr. Daniela Sofra

Lausanne, 1003, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: January 30, 2023
• Primary Completion: July 20, 2023
• Study Completion: October 2, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-08

Locations

CH (1)