Bioenergetic Effect of Pioglitazone in CLD-PH

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06336798
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Hypertension
  • Pulmonary Hypertension Due to Lung Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone 30mg — DRUG
    Study participants will take Pioglitazone 30 mg PO daily
  • Placebo — DRUG
    Study participants will take a placebo PO daily
  • Labs — DIAGNOSTIC_TEST
    Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).

Study Details

The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is: • Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD. Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo).

Key Dates

Start date
Dec 17, 2024
Status verified
Jul 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Pioglitazone, Then Placebo
    Participants will first receive a 30 mg tablet of Pioglitazone once daily for 28 days. After a washout period of 14 days, they will then receive a Placebo tablet (matching Pioglitazone 30 mg tablet) once daily for 28 days.
  • Experimental: Placebo, Then Pioglitazone
    Participants will first receive a Placebo for 28 days. After a washout period of 14 days, they will then receive a 30 mg Pioglitazone tablet once daily for 28 days.

Primary Outcome Measure

Change in Mitochondrial metabolism parameters: Spare respiratory capacity [ Time Frame: Day 1, Day 28, Day 70 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Healthcare SystemAtlantaGeorgia30322
Jane Gillespie, RN
[email protected]
404-712-8204
Aaron W Trammell, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Healthcare System· Atlanta, GA

Related Studies