Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Diabetes remission
Study Overview
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:
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Diabetes remission
Time Frame: 24 months
Measured as HbA1c (%)
Secondary Outcomes
- Change in waist circumference(24 months)
- Change in body fat(24 months)
- Change in body weight(24 months)
- Change in visceral fat(24 months)
- Number of type 2 diabetes remissions(24 months)
- Change in Body Mass Index (BMI)(24 months)
- Decreases in poglycemic drug treatments(24 months)