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Clinical Trial Details

Trial ID: L2051
Source ID: NCT05098327
Associated Drug: Pioglitazone 30 Mg
Title: Pioglitazone and Insulin Resistance in ADT
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Prostate Cancer|Insulin Resistance|Diabetes Mellitus, Type 2|Androgen Deficiency
Interventions: DRUG: Pioglitazone 30 mg|DRUG: Placebo
Outcome Measures: Primary: HOMA-IR, Change in HOMA-IR (the main index for evaluating insulin resistance) following pioglitazone and placebo treatment., 12 weeks | Secondary: IRS-1 serine phosphorylation, Determine levels of IRS-1 serine phosphorylation in adipose tissue and MNC as a molecular marker of inflammation induced insulin resistance at baseline and after pioglitazone and placebo treatments, 12 weeks|IRβ, Changes in expression of insulin signaling gene (IRβ) in both adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|IRS-1, Changes in expression of insulin signaling gene (IRS-1) in both adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|AKT-2, Changes in expression of insulin signaling gene (AKT-2) in both adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|GLUT-4, Changes in expression of GLUT-4 in adipose tissue between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|TNF-α, Changes in expression of proinflammatory gene (TNF-α) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|IL 1β, Changes in expression of proinflammatory gene (IL 1β) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|IKK-β, Changes in expression of proinflammatory gene (IKK-β) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|SOCS-3, Changes in expression of proinflammatory gene (SOCS-3) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|PTB-1B, Changes in expression of proinflammatory gene (PTB-1B) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|JNK-1, Changes in expression of proinflammatory gene (JNK-1) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks|TLR-4, Changes in expression of proinflammatory gene (TLR-4) that interfere with insulin signaling transduction in adipose tissue and MNC between the ADT and non-ADT groups at baseline and after pioglitazone and placebo treatments in ADT group, 12 weeks
Sponsor/Collaborators: Sponsor: State University of New York at Buffalo | Collaborators: National Center for Advancing Translational Sciences (NCATS)
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-08-01
Completion Date: 2023-03-31
Results First Posted:
Last Update Posted: 2023-08-15
Locations: Diabetes and Endocrinology Research Center of WNY, Buffalo, New York, 14221, United States
URL: https://clinicaltrials.gov/show/NCT05098327