Pioglitazone and Insulin Resistance in ADT

NCT05098327 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: STUDY00005310UL1TR001412
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to establish the mechanisms underlying insulin resistance (reduced insulin action that can lead to high blood sugar and maybe diabetes) in patients undergoing androgen deprivation therapy (ADT) for prostate carcinoma as well as to investigate the role of pioglitazone therapy in reduction/ reversal of that insulin resistance

Conditions

Prostate Cancer; Insulin Resistance; Diabetes Mellitus, Type 2; Androgen Deficiency

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  Change in HOMA-IR (the main index for evaluating insulin resistance) following pioglitazone and placebo treatment.

  12 weeks

Secondary Outcomes (12)

• IRS-1 serine phosphorylation

  12 weeks

• IRβ

  12 weeks

• IRS-1

  12 weeks

• AKT-2

  12 weeks

• GLUT-4

  12 weeks

Study Arms (3)

Prostate cancer on ADT receiving pioglitazone

ACTIVE COMPARATOR

Subjects will receive a 12-week supply of pioglitazone 30 mg dose 1 tab daily

Drug: Pioglitazone 30 mg

Prostate cancer on ADT receiving placebo

PLACEBO COMPARATOR

Subjects will receive a 12 week supply of placebo pills containing cellulose

Drug: Placebo

Prostate cancer not on ADT

NO INTERVENTION

No intervention will be done in this group

Interventions

Pioglitazone 30 mg DRUG

pioglitazone 30 mg dose 1 tab daily will be given for 12 weeks

Also known as: Actos

Prostate cancer on ADT receiving pioglitazone

Placebo DRUG

placebo pills containing cellulose 1 pill daily will be given for 12 weeks

Prostate cancer on ADT receiving placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age ≥18 years of age.
• Body Mass Index of \> 25 kg/m2
• Biopsy-confirmed prostate adenocarcinoma currently on androgen deprivation therapy (ADT) for minimum of 3 months for the ADT group and biopsy-confirmed prostate adenocarcinoma not on ADT for control group
• \. Hemoglobin \> 11 g/dL, Creatinine \< 1.5x ULN and liver function tests \< 2x ULN 6. Participant must be able to read, write, and understand the English language and be able to provide written consent 7. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• Known clinically significant severe COPD, ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
• Any patient with known diabetes (A1c \> 6.4%) or an anti-diabetic drug
• Any condition contraindicating additional blood collection beyond standard of care
• Subjects with known allergy to lidocaine (this is used to anesthetize area for fat biopsy)
• Subjects with known allergy to pioglitazone or other thiazolidinediones
• Subjects with pioglitazone use in last 6 months
• Subjects with congestive Heart Failure Class 3 or 4
• Subjects with osteoporosis, including history of fragility fracture
• Subjects with history of bladder cancer
• Subjects on chronic use of androgens, or opiates in the last 6 months or with panhypopituitarism, congenital HH (hypogonadotropic hypogonadism), prolactinoma, head trauma
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo study procedures.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Diabetes and Endocrinology Research Center of WNY

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paresh Dandona, MD, PhD

  SUNY at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor of Medicine

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: August 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)