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Effects of VLCKD in Metabolic Syndrome

Study acronym: KETO-MI
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Sep 2025 to Jan 31, 2026
    • Study completion pushed from Dec 2025 to Dec 2026
    • Site details revised
    v6
  2. Primary completion date: Sep 2024 to Sep 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Site details revised
    v5
  3. Primary completion date: Mar 2024 to Sep 2024v4
  4. Primary completion date: Mar 2023 to Mar 2024
    • Start date: Mar 25, 2022 to Nov 7, 2022
    • Study completion date: Dec 2023 to Dec 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2022 to Mar 25, 2022
    • Secondary endpoints: 23 to 30
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Azienda Ospedaliero Universitaria Maggiore della Carita
13 trials monitored
See all monitored trials
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
and 1 more disease
VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver. For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014). This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests. 40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).
Trial Details
NCT Number NCT05275608
Lead Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators: Laboratoire THERASCIENCE
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
Related terms Diabetes Mellitus, Type 2, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov