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

NCT ID: NCT05541237

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2024-09-08

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Health

Group Type: NO_INTERVENTION

No interventions assigned to this group

Disease

Group Type: EXPERIMENTAL

Food

Intervention Type: DIETARY_SUPPLEMENT

Food

Interventions

Food

Food

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruxing Zhao, doctor

Role: CONTACT

rusingstar@163.com

865318219322

Jianjun Sun, BS

Role: CONTACT

8618916149662

Facility Contacts

Yujing Sun, PhD

Role: primary

08653182169321

Other Identifiers

QiluH-T2D

Identifier Type: -

Identifier Source: org_study_id