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Status unknownNCT05500937Updated Sep 28, 2022

Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin

A Phase 2/3 interventional study of UDCA in Diabetes Mellitus, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2021, registered Dec 2021).
Phase
Phase 2/3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

At present, it is recognized that statins are the cornerstone of treatment for the prevention of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD); However, at the same time, the increased risk of long-term glucose tolerance and type 2 diabetes mellitus caused by statin therapy has attracted wide attention. The investigators' recent study found that the levels of glycosylated hemoglobin, insulin and C-peptide increased significantly with the extension of follow-up time in patients with hyperlipidemia. At the same time, serum and fecal bile acid metabolism profiles, especially secondary bile acid metabolism, were extensively changed, especially in ursodeoxycholic acid (UDCA), suggesting that the decrease of UDCA is a possible mechanism for statins to induce side effects of diabetes. According to this hypothesis, ursodeoxycholic acid combined with statins may improve the abnormal glucose tolerance caused by statins and maximize the benefit of statins. This study is a multicenter, prospective, randomized, parallel, double-blind placebo-controlled, cohort study. Taking ASCVD patients as the research object, the investigators will compare the changes of glycosylated hemoglobin, fasting blood glucose, fasting insulin, C-peptide and metabolomic indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone and during follow-up, Further evaluate the changes of blood glucose related indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone, clarify the possible mechanism and specific treatment targets of abnormal glucose tolerance caused by statin, and put forward a possible alternative treatment for the disorder of glucose metabolism caused by statin.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years old and \< 80 years old, regardless of gender;
  • For those who had indications for taking statins for more than half a year, glycosylated hemoglobin increased by more than 0.5 and > 6.1% compared with half a year ago;
  • Agree to accept the study treatment plan and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • previous diagnosis of diabetes mellitus;
  • Received hypoglycemic drug treatment;
  • The level of abdominal blood glucose at baseline was ≥ 7mmol / L;
  • Need to take glucocorticoids for a long time;
  • Acute myocardial infarction and stroke occurred in the last 6 months;
  • Severe liver dysfunction;
  • Glomerular filtration rate (EGFR) \< 30ml / min / 1.73m2 (MDRD formula);
  • Malignant tumor;
  • Blood system diseases;
  • Acute or severe systemic infection;
  • Women during pregnancy, lactation and preparation for pregnancy;
  • Alcohol and other drug addicts and mental patients;
  • Patients who are participating in other clinical studies or withdraw from less than 1 month;
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    UDCA 500mg per day

    This group of participants receive UDCA 500mg per day.

    Drug: UDCA

  • Placebo comparator
    Placebo

    This group of participants receive placebo.

    Drug: UDCA

Interventions

  • DrugUDCA

    UDCA vs. placebo together with statin in ASCVD patients

    Also known as: Ursodeoxycholic acid

06

What researchers measure

Primary outcomes

  1. Changes of HbA1c

    Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year

    Time frame: 12 months after enrollment

Secondary outcomes

  1. Concentration of blood lipid

    Time frame: 12 months after enrollment

  2. Concentration of fasting blood glucose

    Time frame: 12 months after enrollment

  3. Concentration of fasting islets

    Time frame: 12 months after enrollment

  4. Concentration of bile acids

    Time frame: 12 months after enrollment

  5. Rate of MACE

    Time frame: 12 months after enrollment

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05500937
Responsible party
Sponsor
First posted
Aug 15, 2022
Start date
Mar 1, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 28, 2022

Study contacts

Jianqing She
Contact
jianqingshe@xjtu.edu.cn
17782959686
Zuyi Yuan
study chair · First Affiliated Hospital Xi'an Jiaotong University

Oversight

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

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Studies of the drug tested here: Ursodeoxycholic Acid

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