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Beta Cell DysfunctionNCT05576168

Related Mechanisms of RBP4 in Glycolipid Metabolism

A study testing overexpression STRA6/miRNA3 in people with Beta Cell Dysfunction, run by Shanghai 10th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Retinol binding protein 4 ( RBP4 ) is a newly discovered adipokine secreted by adipose tissue, which leads to insulin resistance ( IR ) and participates in the occurrence of T2DM. At present, it's not clear whether RBP4 can cause islet β cell dysfunction. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Beta Cell Dysfunction
What is being tested?
overexpression STRA6/miRNA3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 May 2018to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Prior to conducting any trial-related activities, including those conducted to assess the subject's eligibility Informed consent of the subject;
  • Aged 18-60 years at the time of screening;
  • The diagnosis of diabetes was defined as fasting blood glucose above 7.0mmol/ L twice on different days on a normal diet

Who cannot join

  • HIV, hepatitis B or C ( self-reported ) or active pulmonary tuberculosis history :
  • history of malignant tumor ;
  • Severe liver dysfunction or kidney disease ( AST or ALT > 3 times the normal upper limit, or eGFR < 30ml min 1.73 m2 ) ;
  • History of severe cardiovascular and cerebrovascular diseases ( angina pectoris, myocardial infarction or stroke ) in the past 6 months :
  • history of severe gastrointestinal disease or gastrointestinal surgery in the past 12 months ;
  • There are other diseases that affect glucose and lipid metabolism : hyperthyroidism, hypothyroidism, cortex Hyperalcoholism, etc. ;
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  • Secondary diseases or drugs lead to obesity, including : elevated cortisol ( such as Cushing 's syndrome ), sagging Obesity caused by body and hypothalamus injury, obesity caused by weight loss drug reduction / discontinuation, etc.
  • Drugs affecting body weight or energy intake / energy expenditure were used within 3 months before screening, including :
  • Sex steroids ( intravenous, oral or intra-articular ), tricyclic antidepressants, for psychiatric disorders

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiaoyun Cheng

    Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: Shanghai Tenth People's Hospital,School of Medicine,Tongji University

Retinol binding protein 4 ( RBP4 ) is a newly discovered adipokine secreted by adipose tissue, which leads to insulin resistance ( IR ) and participates in the occurrence of T2DM. At present, it's not clear whether RBP4 can cause islet β cell dysfunction. The purpose of this study is to explore the role of serum apo-RBP4 in the pathogenesis of newly diagnosed T2DM patients.

Read the detailed description

In recent years, with the improvement of living standards and lifestyle changes, the incidence of type II diabetes is increasing, and T2DM has become a worldwide disease that seriously endangers people ' s health. When patients with diabetes in the middle and late, the condition is often irreversible, and early if effective treatment, help to improve the condition in a timely manner, delay the development of the disease process. Therefore, early diagnosis and treatment is the key to prevention and treatment of diabetes. Years of studies have shown that insulin resistance and β-cell dysfunction are the two major mechanisms of type II diabetes. Previous studies on the pathogenesis of type II diabetes mostly focused on insulin resistance, and there are few studies on β-cell dysfunction. Therefore, the study of islet β-cell dysfunction is extremely important. According to previous studies, the investigator found that although insulin resistance exists in type II diabetes, also exists to the same extent in many people who do not have diabetes. These people may have or do not have metabolic syndrome. Therefore, insulin resistance alone cannot be the decisive pathogenic factor of type II diabetes, and the increasing facts indicate that the abnormality of islet cells, especially islet β cells, may be the central link in the pathogenesis of type II diabetes. Obviously, insulin resistance is the initiating factor of type II diabetes, and the normal function of islet β cells is the determinant of whether type II diabetes occurs : the occurrence of insulin resistance initiates the pathogenesis of type II diabetes, but if the islet β cells can maintain its compensatory ability, type II diabetes will not occur. Once its compensatory ability decreases, type II diabetes gradually occurs. Therefore, islet β cell dysfunction is the key to the pathogenesis of type II diabetes. Exploring the harmful factors that impair β-cell function is critical for early prevention and treatment of diabetes.

Being tested
overexpression STRA6/miRNA3
Keywords
Retinol binding protein 4, beta cell dysfunction, glycolipid metabolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • overexpression STRA6/miRNA3Biological

    Also called RBP4 express in T2DM patients

    RBP4 express in patients with T2DM or not

Study groups in NCT05576168
Study groupRoleWhat they receive
T2DM groupExperimentalpatients with T2DM
Receives: Biological: overexpression STRA6/miRNA3
control groupActive comparatorpatients without T2DM
Receives: Biological: overexpression STRA6/miRNA3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RBP4

    Retinol binding protein 4

    Measured: 3 years

Secondary outcomes (17)

  1. BMI

    BMI=weight(kg)/heihgt(m)^2

    Measured: 3 years

  2. TT

    total testosterone in mmol/L

    Measured: 3 years

  3. FBG

    fasting blood-glucose in mmol/L

    Measured: 3 years

  4. PBG

    postprandial blood-glucose in mmol-L

    Measured: 3 years

  5. FINS

    fasting serum insulin in mU/L

    Measured: 3 years

  6. PINS

    postprandial serum insulin in mU/L

    Measured: 3 years

  7. ALT

    alanine aminotransferase in U/L

    Measured: 3 years

  8. AST

    aspartate aminotransferase in U/L

    Measured: 3 years

  9. UA

    Uric acid in umol/L

    Measured: 3 years

  10. HOMA-IR

    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5

    Measured: 3 years

  11. HbA1c(%)

    Glycated hemoglobin

    Measured: 3 years

  12. FT

    free testosterone (nmol/L)

    Measured: 3 years

  13. LDL-C

    low-density lipoprotein cholesterol in mmol/L

    Measured: 3 years

  14. HDL-C

    Hight-density lipoprotein cholesterol in mmol/L

    Measured: 3 years

  15. FSH

    follicle-stimulating hormone in IU/L

    Measured: 3 years

  16. TC

    Total Cholesterol(mmol/L)

    Measured: 3 years

  17. TG

    Triglyceride(mmol/L)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start1 May 2018
  3. Primary completion1 Jun 2020
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Serum RBP4 level in patients with or without type 2 diabetes
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05576168
Sponsor's protocol ID
RBP4
Status last verified
Oct 2022
First submitted
28 Sep 2022
Last updated
12 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Weng Q, Zhao M, Zheng J, Yang L, Xu Z, Zhang Z, Wang J, Wang J, Yang B, Richard Lu Q, Ying M, He Q. STAT3 dictates beta-cell apoptosis by modulating PTEN in streptozocin-induced hyperglycemia. Cell Death Differ. 2020 Jan;27(1):130-145. doi: 10.1038/s41418-019-0344-3. Epub 2019 May 16.

    PubMed 31097787

Questions about this trial

What is this clinical trial studying?

A study testing overexpression STRA6/miRNA3 in people with Beta Cell Dysfunction, run by Shanghai 10th People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RBP4 (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576168, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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