Pharmacogenomics of Thiazolidinediones

NCT01135394 | Completed Results DMC

• 2 other identifiers: HP-00043497R01DK074828
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine predictors of response to pioglitazone, an anti-diabetic medication. The investigators know from randomized clinical trials that some 30% of patients do not respond to this type of medication. There is presently no way to identify this group of patients leading to unnecessary drug exposure and medication costs.

Conditions

Type 2 Diabetes

Keywords

Pioglitazone; Type 2 diabetes; Insulin sensitivity; Healthy adults; Thiazolidinediones; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance

  Change in insulin resistance was calculated as change (end of treatment minus baseline) in HOMA-IR index (glucose (mg/dL) x insulin (μU/mL)/405)

  12 weeks

Secondary Outcomes (1)

• Number of Genes Determined to be Correlated With Change in Insulin Sensitivity

  12 weeks

Study Arms (1)

Pioglitazone (Actos)

EXPERIMENTAL

Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.

Also known as: Actos

Pioglitazone (Actos)

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-64
• BMI: ≥ 25 and ≤ 40

You may not qualify if:

• Pregnancy as determined by urine pregnancy test Breast-feeding, or planning to become pregnant during the study
• Physical dimensions exceeding the limits of any equipment used
• Stage III or greater congestive heart failure
• Symptomatic peripheral vascular disease
• Stroke
• Severe hypertension (\>170/100 mmHg)
• Anemia (Hgb and Hct \< normal reference range)
• Receiving treatment for thyroid, pituitary, kidney or liver disease (except controlled thyroid hormone replacement)
• History of diabetes (as told by doctor, or taking diabetic medications Fasting glucose value diagnostic for diabetes 2-h oral glucose tolerance test diagnostic for diabetes
• Rheumatoid arthritis
• History of wrist, hip or leg fracture after the age of 45
• History of kidney stones
• Medications that the investigator judges will make interpretation of the results difficult or increase the risk of participation (e.g. anticoagulants)
• Any disease or condition that the investigator judges will affect bone metabolism or make interpretation of the results difficult or increase the risk of participation (e.g. anemia, cardiac decompensation, intolerance to pioglitazone, lidocaine, or other agents used)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Soren Snitker, MD, PhD
• Organization: University of Maryland School of Medicine

ssnitker@som.umaryland.edu

4107061511

Study Officials

• Soren Snitker, MD, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: March 1, 2009
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: March 15, 2024
• Results First Posted: May 18, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)