Effects of GLP-1 Receptor Agonists on Diabetes and Body Fat

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

This study is testing different GLP-1 medications to see how well they help people with type 2 diabetes manage their blood sugar, body fat, and weight over 1 to 4 years.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT05990374 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term efficacy of various GLP-1 receptor agonists, including Duragtide, Semaglutide, losenatide, tirzepatide, and ebenatide, in patients with type 2 diabetes over a follow-up period of 1 to 4 years. It aims to assess their impact on blood glucose levels, body fat, insulin resistance, body weight, blood lipids, and stomach volume. The study will also explore factors influencing treatment efficacy to provide evidence-based insights for diabetes management.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with type 2 diabetes who have not achieved adequate glycemic control despite diet and exercise.

Not a fit: Patients currently using GLP-1 receptor agonists or other specific diabetes medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of blood glucose and body fat in patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with GLP-1 receptor agonists, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Nanjing

• Nanjing First Hospital, Nanjing Medical Univesity — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Bingli Liu

Conditions: Diabetes