Prostate Cancer Clinical Trial
Official title:
Role of Pioglitazone Therapy in Management of Insulin Resistance Associated With Androgen Deprivation Therapy (ADT) in Patients With Prostate Cancer
Verified date | August 2023 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male, age =18 years of age. 2. Body Mass Index of > 25 kg/m2 3. 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 5. 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 Exclusion Criteria: 1. Known clinically significant severe COPD, ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias 2. Any patient with known diabetes (A1c > 6.4%) or an anti-diabetic drug 3. Any condition contraindicating additional blood collection beyond standard of care 4. Subjects with known allergy to lidocaine (this is used to anesthetize area for fat biopsy) 5. Subjects with known allergy to pioglitazone or other thiazolidinediones 6. Subjects with pioglitazone use in last 6 months 7. Subjects with congestive Heart Failure Class 3 or 4 8. Subjects with osteoporosis, including history of fragility fracture 9. Subjects with history of bladder cancer 10. Subjects on chronic use of androgens, or opiates in the last 6 months or with panhypopituitarism, congenital HH (hypogonadotropic hypogonadism), prolactinoma, head trauma 11. Unwilling or unable to follow protocol requirements 12. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo study procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Diabetes and Endocrinology Research Center of WNY | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo | National Center for Advancing Translational Sciences (NCATS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | IRß | Changes in expression of insulin signaling gene (IRß) 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | TNF-a | Changes in expression of proinflammatory gene (TNF-a) 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 | |
Secondary | IL 1ß | Changes in expression of proinflammatory gene (IL 1ß) 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 | |
Secondary | IKK-ß | Changes in expression of proinflammatory gene (IKK-ß) 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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