Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

NCT01588470 | Completed Phase 4 Results

• 2 other identifiers: MM20060280T001
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.

Conditions

Type 2 Diabetes; Coronary Heart Disease

Keywords

diastolic function; mitochondria; pioglitazone; pericardial fat

Outcome Measures

Primary Outcomes (2)

• Change in E to A Ratio

  The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.

  Baseline and 6-months Post Treatment

• Myocardial Glucose Uptake

  Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone

  Baseline and 6-months Post Treatment

Secondary Outcomes (1)

• Change in Hemoglobin A1c

  Baseline and 6-months Post Treatment

Study Arms (1)

Pioglitazone

EXPERIMENTAL

Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone

Drug: pioglitazone

Interventions

pioglitazone DRUG

45 mg per day for 6 months

Also known as: Actos

Pioglitazone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
• Patients may be of either sex. Female patients must be non-lactating and must either be at least one year post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period
• Patients must range in age from 18 to 75 years, inclusive.
• Patients with type 2 diabetes must be drug naïve, receiving monotherapy with metformin or with a sulfonylurea, or combination therapy with both: metformin \& sulfonylurea.
• Patients must have the following laboratory values:
• Hematocrit ≥ 34 vol%
• Serum creatinine ≤ 1.8 mg/dl
• AST (SGOT) ≤ 2.5 times upper limit of normal
• ALT (SGPT) ≤ 2.5 times upper limit of normal
• Alkaline phosphatase ≤ 2 times upper limit of normal
• Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
• Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

You may not qualify if:

• Patients must not have type 1 diabetes.
• Patients must not be receiving any medications with known adverse effects on glucose tolerance (except metformin or a sulfonylurea) unless the patient has been on stable doses of such agents for the past three months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy, if the patient has been on these agents for the prior three months. Patients taking systemic glucocorticoids are excluded.
• Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
• Patients with hematocrit \< 34% will be excluded.
• Patient who were exposed to any procedure involves radiation exposure and his total radiation dose equivalent exceeds 5 rem during the past year will be excluded from the study.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Related Publications (1)

• Clarke GD, Solis-Herrera C, Molina-Wilkins M, Martinez S, Merovci A, Cersosimo E, Chilton RJ, Iozzo P, Gastaldelli A, Abdul-Ghani M, DeFronzo RA. Pioglitazone Improves Left Ventricular Diastolic Function in Subjects With Diabetes. Diabetes Care. 2017 Nov;40(11):1530-1536. doi: 10.2337/dc17-0078. Epub 2017 Aug 28.

  PMID: 28847910 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Disease

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Muhammad Abdul-Ghani, MD
• Organization: UT Health Science, San Antonio

abdulghani@uthscsa.edu

210-567-6691

Study Officials

• Ralph A DeFronzo, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Division Chief, Department of Medicine, Division of Diabetes

Model Details: this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment. as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: May 1, 2012
• Study Start: June 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share