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Insulin Resistance and Androgen Deprivation Therapy

Phase 2
Waitlist Available
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial tests pioglitazone, a drug that helps control blood sugar, in men with prostate cancer who are on a treatment that often causes insulin resistance. The goal is to see if pioglitazone can reduce this side effect. Pioglitazone is a medication that improves insulin sensitivity and has been used to treat type 2 diabetes by lowering blood glucose levels and improving lipid profiles.

Eligible Conditions
  • Insulin Resistance
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
insulin sensitivity
Secondary study objectives
Insulin signaling (Insulin receptor substrate expression in fat tissue)

Side effects data

From 2013 Phase 3 trial • 936 Patients • NCT01183013
8%
Oedema peripheral
7%
Nasopharyngitis
7%
Hyperglycaemia
5%
Urinary tract infection
5%
Headache
5%
Dizziness
4%
Upper respiratory tract infection
4%
Arthralgia
4%
Back pain
4%
Pain in extremity
3%
Bronchitis
3%
Hypertension
1%
Retinal artery embolism
1%
Myocardial infarction
1%
Constipation
1%
Congestive cardiomyopathy
1%
Gastrointestinal haemorrhage
1%
Appendicitis
1%
Basal cell carcinoma
1%
Renal cell carcinoma
1%
Sleep apnoea syndrome
1%
Oedema
1%
Acute myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pio30/Pio30
Lina5Pio45/Lina5Pio45
Lina5/Lina5
Pio15/Pio30
Pio45/Pio45
Lina5Pio15/Lina5Pio30
Lina5Pio30/Lina5Pio30

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PioglitazoneExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone 30 mg
2021
Completed Phase 4
~1770

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
41,023 Total Patients Enrolled
1 Trials studying Insulin Resistance
~0 spots leftby Dec 2025
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