Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled RCT (T2D)

Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled Randomized Controlled Trials

This study is a randomized, open labelled, placebo-controlled clinical trial. The main purpose is to verify the superior effect of gut microbiota directed diet intervention over standard diet intervention by evaluating the changes of HbA1c relative to baseline at 16 weeks and 28 weeks of follow-up.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Food

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruxing Zhao, doctor; Phone Number: 865318219322; Email: rusingstar@163.com
• Study Contact Backup: Name: Jianjun Sun, BS; Phone Number: 8618916149662

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yujing Sun, PhD; Phone Number: 08653182169321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newly diagnosed type 2 diabetes mellitus patients who have been diagnosed or screened for treatment without any hypoglycemic drugs;
• 6.5%≤HbA1c≤8.5%；
• FPG<10.0mmol/L;
• BMI≥24；

Exclusion Criteria:

• suspected other types of diabetes
• Moderate stroke occurred within one year;
• Frequent diarrhea or constipation in the past 3 months (more than 4 times / week);
• Acute complications occurred in the past 3 months, such as infection, ketosis and acidosis;
• Pregnant and lactating women (or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives);
• Drinking (1 weeks of drinking more than 5 times, on average 2 two Baijiu or half Jin of yellow wine or 5 bottles of beer above);
• Those who have received drug treatment for the following diseases in the past three months: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction;
• Gastrointestinal surgery (except appendicitis and hernia surgery);
• Antibiotics have been used in the past 3 months for 3 days or more;
• Physical methods, such as liposuction or gastrointestinal reconstruction, have been used to lose weight in the past 3 months;
• Physical disability, or inability to take care of themselves, recall and answer questions clearly due to other reasons;
• Anemia: hemoglobin < 10g / dl;
• Patients with severe liver diseases such as chronic hepatitis, persistent hepatitis and cirrhosis, and hepatitis B virus surface antigen (HBsAg) positive and abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value).
• Other serious diseases, such as malignant tumors, serious mental diseases, serious infectious diseases, etc;
• Patients who are participating in other intervention studies;
• In the judgment of the study physician, there are any conditions that affect the study compliance, such as:Alcohol or drug abuse in the past 12 months; Serious adverse drug treatment compliance in the past 12 months; The residence is far away from the research center, or it is planned to move far away or travel frequently in the next year; The clinical diagnosis of dementia or the judgment of cognitive function by the research physician will affect the research compliance; Other medical, psychological or behavioral factors that affect the study compliance are judged by the study physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Health
Experimental: Disease	Dietary supplement: Food; Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of HbA1c compared with baseline	changes of HbA1c compared with baseline	28 weeks
remission rate	remission rate of T2D by ADA guideline；ratio of subjects whose blood glucose can reach completely normal without drug intervention	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
control rate	Proportion of subjects with HbA1c < 7.0%	at 16 weeks of treatment and 28 weeks of follow-up
blood lipid profile	Changes of blood lipids (total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol) relative to baseline	at 16 weeks of treatment and 28 weeks of follow-up

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Anticipated): September 5, 2023
• Study Completion (Anticipated): September 8, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: QiluH-T2D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No