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NCT Number: NCT05984459

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Daniela Sofra

Lausanne, 1003, Switzerland

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Diabetes remission

    Time frame: 24 months

    Measured as HbA1c (%)

Secondary outcomes

  1. Change in body weight

    Time frame: 24 months

    Measured as kilograms (kg)

  2. Change in body fat

    Time frame: 24 months

    Measuared in percentage (%)

  3. Change in visceral fat

    Time frame: 24 months

    Measuared in percentage (%)

  4. Change in waist circumference

    Time frame: 24 months

    Measured in percentage (%)

  5. Change in Body Mass Index (BMI)

    Time frame: 24 months

    Measured in kilogram per square meter (kg/m^2)

  6. Number of type 2 diabetes remissions

    Time frame: 24 months

    Measured as count of participants

  7. Decreases in poglycemic drug treatments

    Time frame: 24 months

    Measured as changes in the number of diabetes treatments

Sponsors and collaborators

Lead sponsor

Cabinet Medical

Other

Collaborators

  • Trialance SCCL

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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