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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Diseases

Treatments: Drug: dulaglutide injection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05254418

220057

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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7 participants in 1 patient group

dulagutide arm

Experimental group

Description:

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

Treatment:

Drug: dulaglutide injection