Related Mechanisms of RBP4 in Glycolipid Metabolism

NCT05576168 | Completed

• 1 other identifier: RBP4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. The purpose of this study is to explore the role of serum apo-RBP4 in the pathogenesis of newly diagnosed T2DM patients.

Conditions

Beta Cell Dysfunction

Keywords

Retinol binding protein 4; beta cell dysfunction; glycolipid metabolism

Outcome Measures

Primary Outcomes (1)

• RBP4

  Retinol binding protein 4

  3 years

Secondary Outcomes (17)

• BMI

  3 years

• TT

  3 years

• FBG

  3 years

• PBG

  3 years

• FINS

  3 years

Study Arms (2)

T2DM group

EXPERIMENTAL

patients with T2DM

Biological: overexpression STRA6/miRNA3

control group

ACTIVE COMPARATOR

patients without T2DM

Biological: overexpression STRA6/miRNA3

Interventions

overexpression STRA6/miRNA3 BIOLOGICAL

RBP4 express in patients with T2DM or not

Also known as: RBP4 express in T2DM patients

T2DM group; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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. ;
• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Xiaoyun Cheng

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• 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.

  PMID: 31097787 RESULT

Study Officials

• Shen Qu, Dr

  Department of Endocrinology,Shang hai Tenth People's Hostipal,Shang hai,Shanghai,China,200070

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Serum RBP4 level in patients with or without type 2 diabetes

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 12, 2022
• Study Start: May 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2021
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

CN (1)