Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Diabetes Clinical Trial

Official title:

Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990374
• Other study ID #: KY20220825-04
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Bingli Liu
• Phone: +86 15366110069
• Email: lxmxjtu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

Description:

At present, there has been no evaluation on the efficacy of long-term treatment of different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects of long-term treatment on patients' blood glucose and body fat. This study intends to follow up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more evidence-based medical evidence for drug treatment and benefit patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosed type 2 diabetes according to the 1999 WHO standards;

2. received at least 8 weeks of simple diet control and physical exercise before screening; Patients with type 2 diabetes who were treated with stable hypoglycemic drugs and had inadequate glycemic control within 8 weeks prior to screening;

3. HbA1c=7.5%;

4. BMI>24kg/m2;

5. Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG);

6. Be willing to sign written informed consent and comply with the study protocol

Exclusion Criteria:

1. Use of any of the following drugs or treatments in the 3 months prior to screening:

treatment with GLP-1RA, GLP-1 analogue, DPP-4 inhibitor, or any other incretin analogue;

2. Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening;

3. Use of weight control drugs or surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss program and not in the maintenance stage:

4. History of acute and chronic pancreatitis; A history of medullary C-cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history;

5. Clinically significant gastric emptying abnormalities;

6. tumors of any organ system that have been treated or not treated in the 5 years prior to screening;

7. had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. Negligent compensatory heart failure (NYHA rating III and IV), stroke or transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia;

8. Acute metabolic complications occurred within 6 months before screening;

9. Before screening, any of the laboratory test indicators meet the following criteria:

glutamic-pyrugenic transaminase >2.5 times or ASpartate transaminase >2.5 times; eGFR <45ml/min/1.73m2; Fasting glycerin tricol >5.64mmol/L.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical Univesity	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of different GLP-1 on blood glucose	The changes of blood glucose fluctuation after treatment	1,2,3,4 year
Secondary	Effects of different GLP-1 on body fat mass	The changes of body fat mass after treatment	1,2,3,4 year