Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorWestlake University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 2 diabetes;

Living in Hangzhou for at least five years;

Have the willingness or ability to complete the intervention and sample collection

Disqualifiers

Mental and physical disability;

Already is a vegetarian;

Cancer and serious complications from type 2 diabetes, such as renal failure;

Using insulin for more than 5 years;

Trial design

Design model

Parallel

Treatments tested in this trial

  • White bread

    Other intervention

    After wearing CGM on Day 1, participants will be provided with white bread (76-77g) and milk (250mL) for breakfast on Day 3, Day 4, Day 7, Day 8, Day 10, Day 12.

  • Whole wheat bread

    Other intervention

    After wearing CGM on Day 1, participants will be provided with wheat bread (85-86g) and milk (250mL) for breakfast on Day 2, Day 5, Day 6, Day 9, Day 11, Day 13.

  • Plant-based diet

    Behavioral

    After wearing CGM on Day 1, participants will be asked to follow the plant-based diet in next 30 days.

  • Conventional diabetic diet

    Other intervention

    Volunteers will be asked to have a diet following 2023 Chinese Diabetes Society guidelines in next 30 days.

  • Follow-up visit every 1-2 years

    Other intervention

    Participants will be visited every 1-2 years. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, ultrasonography evaluation, laboratory tests, and multi-omics data will be conducted.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Plant-based dietExperimental treatment 4 interventions
Group B: Conventional diabetic dietExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Changes in gut microbiome profile

Shotgun metagenomic sequencing will be performed in stool samples.

Time frame
Day 1 and Day 31
2

Blood glucose profile

Real-time blood glucose fluctuations will be recorded using continuous glucose monitoring.

Time frame
2 weeks

Secondary outcomes

1

Carotid plaque

Grade carotid plaque using ultrasound.

Time frame
At enrollment
2

Carotid intima-media thickness

Measure of carotid intima-media thickness using ultrasound.

Time frame
At enrollment
3

Number of participants with chronic kidney disease

The serum creatine and urine creatine and protein will be measured and chronic kidney disease will be defined as an estimated glomerular filtration rate of \<60 mL/min/1.73 m2 or and the presence of an elevated urine microalbumin/creatinine ratio. All cases will be verified by medical record review.

Time frame
Up to 10 years
4

Cognitive function

Cognitive function was measured by the Addenbrooke's Cognitive Examination-Revised (ACE-R). The original 26 components were combined to produce five subscores, 100 in total. The cutoff for dementia is 82-88/100.

Time frame
Up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westlake University

Lead sponsor

The Third People's Hospital of Hangzhou

Collaborator

Source ClinicalTrials.gov
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