The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 144 participants (planned 200)
    • Study completion date changed from estimate of Dec 1, 2033 to Jan 4, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 8 to 4
    • Site details revised at 2 of 2 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Primary completion date: Dec 1, 2024 to Dec 31, 2025v4
  3. Enrollment target: 1500 to 200
    • Study description expanded, about 1 word
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of May 30, 2023 to Jul 17, 2023
    v2
  5. Study First Submitted
  • 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.
Westlake University
13 trials monitored
See 2 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Type 2 Diabetes
2,236 trials monitored
See 113 trials at risk
Food plays a crucial role in determining blood glucose levels, especially in people with type 2 diabetes. Precision nutrition, which involves individually tailored dietary interventions, can be a powerful tool in managing blood glucose levels in people with type 2 diabetes. Previous studies found that changes in gut microbiota resulted from the dietary intervention, such as plant-based diet, might subsequently lead to different glycemic responses, and then different health outcomes. In this study, the investigators will characterize the blood glucose dynamics and gut microbiota of individuals with type 2 diabetes. They aim to assess the influence of plant-based diet on gut microbiota; they will also investigate the influence of gut microbiota on glycemic responses. Additionally, a series of individual N-of-1 trails will be integrated to compare the effects of a white bread breakfast and a whole wheat bread breakfast on glucose metabolism at the individual level.
Trial Details
NCT Number NCT05885828
Lead Sponsor Westlake University
Collaborators: The Third People's Hospital of Hangzhou
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov