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Status unknownNCT05541237T2DUpdated Mar 24, 2023

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

An interventional study of Food in Type 2 Diabetes, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Health
  • Experimental
    Disease

    Dietary Supplement: Food

Interventions

  • Dietary supplementFood

    Food

06

What researchers measure

Primary outcomes

  1. changes of HbA1c compared with baseline

    changes of HbA1c compared with baseline

    Time frame: 28 weeks

  2. remission rate

    remission rate of T2D by ADA guideline;ratio of subjects whose blood glucose can reach completely normal without drug intervention

    Time frame: 28 weeks

Secondary outcomes

  1. control rate

    Proportion of subjects with HbA1c \< 7.0%

    Time frame: at 16 weeks of treatment and 28 weeks of follow-up

  2. blood lipid profile

    Changes of blood lipids (total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol) relative to baseline

    Time frame: at 16 weeks of treatment and 28 weeks of follow-up

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    • Yujing Sun, PhD · Contact · 08653182169321
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05541237
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
Sep 15, 2022
Start date
Aug 17, 2022
Primary completion
Sep 5, 2023 (estimated)
Completion
Sep 8, 2024 (estimated)
Last update
Mar 24, 2023

Study contacts

Ruxing Zhao, doctor
Contact
rusingstar@163.com
865318219322
Jianjun Sun, BS
Contact
8618916149662

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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