NCT05541237

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2024

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

September 12, 2022

Last Update Submit

March 22, 2023

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • control rate

    at 16 weeks of treatment and 28 weeks of follow-up

  • blood lipid profile

    at 16 weeks of treatment and 28 weeks of follow-up

Study Arms (2)

Health

NO INTERVENTION

Disease

EXPERIMENTAL
Dietary Supplement: Food

Interventions

FoodDIETARY_SUPPLEMENT

Food

Disease

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Food

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Ruxing Zhao, doctor

CONTACT

865318219322rusingstar@163.com

Jianjun Sun, BS

CONTACT

8618916149662

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

August 17, 2022

Primary Completion

September 5, 2023

Study Completion

September 8, 2024

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

CN(1)