Type 2 Diabetes Treatment and Remission With a Very Low-calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
Study Details
Study Description
Brief Summary
There is a close association between overweight, abdominal type, and type 2 diabetes mellitus (T2DM).The scientific literature of recent years shows the existing relationship between weight loss, of 15% or more of body weight, and the positive effect on body composition parameters as well as on glycemic profiles. Specifically, here the investigator focuses on very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess weight and improving diabetes. Current knowledge is changing the face of T2DM, showing that an effective, appropriate and early intervention can lead to a remission of diabetes involving a partial recovery of insulin secretion as well as its action.
Nevertheless, the daily life of the diabetic patient followed in an office can be less linear than that of a patient participating in a study protocol, with planned follow-up visits and close supervision. What about the impact of VLCKD, observed in clinical studies, in patients with T2DM in real-life? In order to answer this question, we would like to analyze here a series of patient files with T2DM and overweight, followed in a private practice, specializing in diabetology, who have adhered to a VLCKD, by a commercial method (PnK® Method), in order to improve their glycemic control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 our 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
Outcome Measures
Primary Outcome Measures
- Diabetes remission [24 months]
Measured as HbA1c (%)
Secondary Outcome Measures
- Change in body weight [24 months]
Measured as kilograms (kg)
- Change in body fat [24 months]
Measuared in percentage (%)
- Change in visceral fat [24 months]
Measuared in percentage (%)
- Change in waist circumference [24 months]
Measured in percentage (%)
- Change in Body Mass Index (BMI) [24 months]
Measured in kilogram per square meter (kg/m^2)
- Number of type 2 diabetes remissions [24 months]
Measured as count of participants
- Decreases in poglycemic drug treatments [24 months]
Measured as changes in the number of diabetes treatments
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a diagnosis of type 2 diabetes
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Being overweight (BMI > 25 kg/m2) or obesity (BMI > 29.9 kg/m2)
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Have wished to engage in a weight loss program according to the PnK® method
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Have accepted and signed the consent for the use of data
Exclusion Criteria:
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Pregnancy or lactation
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Type 1 diabetes
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Eating disorders
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Psychiatric disorders
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Have any contraindication for doing the active or ketogenic phase
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Daniela Sofra | Lausanne | Switzerland | 1003 |
Sponsors and Collaborators
- Cabinet Medical
- Trialance SCCL
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FMH Endocrinol and Diabetol