Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

NCT ID: NCT05254418

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-08-01

Brief Summary

Chronic kidney disease (CKD) is a burden of morbidity and mortality. Increased protein breakdown in skeletal muscle (wasting) and ectopic fat deposition are important determinants of poor clinical outcome in patient with CKD. Insulin resistance plays a critical role in skeletal muscle wasting and ectopic fat deposition. Glucagon-like peptide-1 receptor agonists (GLP-1RA) decrease ectopic fat deposition in patients with type 2 diabetes, prediabetes, obese and overweight subjects.

The influence of GLP-1RA on ectopic fat deposition in CKD patients in unknown. The investigators' will test the hypothesis that GLP-1RA decreases intermuscular (ectopic) fat deposition in patients with stage 3-4 CKD. The investigators' will do so by addressing the following specific aims:

Specific Aim 1: To test the hypothesis that GLP-1RA decreases intermuscular fat deposition in patients with stage 3-4 CKD.

Specific Aim 2: To test the hypothesis that GLP-1RA improves skeletal muscle mitochondrial function in patients with stage 3-4 CKD.

Specific Aim 3: To test the hypothesis that GLP-1RA improves physical performance in patients with stage 3-4 CKD.

Specific Aim 4: To test the safety and feasibility of 12 weeks of dulaglutide 1.5 mg/wk administration as an adjunct therapy to the standard care of patients with stage 3-4 CKD.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

dulagutide arm

Patient will receive 1.5 mg injections per week for 12 weeks.

Group Type: EXPERIMENTAL

dulaglutide injection

Intervention Type: DRUG

All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication

Interventions

dulaglutide injection

All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)

2. Age ≥ 18 years and ≤75 years

Exclusion Criteria

1. Patients with type 1 diabetes mellitus

2. Patients with T2D who are on insulin therapy or who started a new antidiabetic medication within 1 month prior to study or who received incretin-based therapy within 3 months prior to study

3. BMI <25 kg/m2, BMI >40 kg/m2

4. HbA1c>8% measured within 1 month prior to study, or a history of hypoglycemic episode within 1 year prior to study, or a history of diabetic ketoacidosis

5. Uncontrolled hypertension (>200/100 mmHg) despite optimal antihypertensive therapy

6. Arrythmia, heart failure (NYHA class III-IV), valve disease or heart diseases other than coronary artery disease

7. History of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis

8. Personal or family history of medullary thyroid cancer, or personal history of Multiple Endocrine Neoplasia (MEN)-2

9. Pregnancy, breast feeding or intention to become pregnant

10. Previous renal transplantation

11. Acute or chronic infectious diseases

12. Cancer or chemotherapy within 3 years prior to study

13. Treatment with systemic corticosteroids within 3 months prior to study

14. Known or suspected allergy to dulaglutide

15. Claustrophobia or other contraindications for magnetic resonance imaging

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Tennessee Valley Health Care System

FED

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alp Ikizler

Catherine McLaughlin Hakim Chair in Vascular Biology, Professor of Medicine, Director, Division of Nephrology and Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

220057

Identifier Type: -

Identifier Source: org_study_id