Clinical trial NCT05885828: The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes
Official title: The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: N-of-1
plant-based diet
precision nutrition
continuous glucose monitoring
type 2 diabetes
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: The Third People's Hospital of Hangzhou
First posted: 2023-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Choice of design: The study is a two-arm intervention study integrated with N-of-1 design.

Study population: Patients with type 2 diabetes.

Screening Assessment: Prospective participants will be selected based on the pre-defined inclusion and exclusion criteria. Recruitment will be done over the phone and via the social media.

Study duration: Each participant will take part in the study for a period of up to 1 month at baseline and have follow-up visits every 1-2 years.

Dietary intervention:

The PRECISION-T2D is a dietary intervention study. Upon admission, patients will be randomly assigned to two groups: plant-based diet and conventional diabetic diet. Throughout the hospitalization, all participants (n=200) will be given standardized meals. A dietitian will design the diet for both plant-based and conventional diabetic diet groups following 2023 Chinese Diabetes Society guidelines. Both diets comprised approximately 50-65% of energy from carbohydrates, 20-30% of energy from fat, 15-20% from protein. The plant-based diet had higher fiber content (25-30g) compared to the conventional diabetic diet (15-20g). Participants will be asked to consume the entire amount of food indicated for the standardized meals and to record any leftover food. All participants will be asked to track their meals, snacks and drinks with instructions on how to record their daily dietary information. Participants will also be advised not to modify their exercise habits during the course of the study. Upon discharge, Participants in the plant-based diet arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. Participants in the conventional diabetic diet arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. Individual N-of-1 trial design will be employed to all participants during day one to day twelve to compare the difference of postprandial glucose response to white bread or whole wheat bread. These two standard breakfasts will appear in pseudo-random order. During the participants' first baseline visit day, they will be asked to complete a baseline questionnaire to collect information on their lifestyle, dietary habits, history of medications, sleep quality and appetite. Anthropometric measurements, ultrasonography evaluation, and laboratory tests will be taken using standard protocols. Participants will then be asked to wear a continuous glucose monitor (CGM) for 14-day blood glucose monitoring, which will be done by a nurse. On day 14, participants will be asked to come in for a clinical visit where they will receive their CGM report and provide blood, saliva, urine and stool samples. On day 30, participants will be asked to come in for another clinical visit where they will provide blood, saliva, urine and stool samples.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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;
* Unstable medical/medication status;
* Current alcohol or drug abuse;
* Taking antibiotics in the last three months

Primary outcomes:
measure: Changes in gut microbiome profile
timeFrame: Day 1 and Day 31
measure: Blood glucose profile
timeFrame: 2 weeks
Secondary outcomes:
measure: Carotid plaque
timeFrame: At enrollment
measure: Carotid intima-media thickness
timeFrame: At enrollment
measure: Number of participants with chronic kidney disease
timeFrame: Up to 10 years
measure: Cognitive function
timeFrame: Up to 10 years
measure: Changes in fasting blood glucose
timeFrame: Day 1 and Day 31
measure: Changes in fasting blood C-peptide
timeFrame: Day 1 and Day 31
measure: Changes in fasting blood HbA1c
timeFrame: Day 1 and Day 31
measure: Changes in lipid metabolism
timeFrame: Day 1 and Day 31
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: