Thiazolidinedione (TZD) on the Diabetic Retinopathy and Nephropathy

NCT01175486 | Unknown Phase 4

• 1 other identifier: 201004014IA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Thiazolidinediones (TZDs) are insulin sensitizers that decrease plasma glucose in type 2 diabetic patients. Thiazolidinediones can cause fluid retention and peripheral edema in diabetic patients, and the systematic fluid retention can be manifested as diabetic macular edema (DME). The overall goal of this study is to examine the effects of thiazolidinediones on the diabetic retinopathy and nephropathy. Study design: This is a prospective, randomized, open-labeled, controlled design to assess the effects thiozolidinediones on the diabetic retinopathy and nephropathy. The investigators will recruit 300 type 2 diabetic patients without significant retinopathy, nephropathy and cardiovascular disease. Inclusion criteria are type 2 diabetes, age between 30-80 years old, with microabluminuria, no significant retinopathy, on submaximal dose of sulphonylureas and metformin treatment, and A1C between 7-9%. Exclusion criteria are on insulin treatment, significant retinopathy and significant nephropathy. Patients with cardiovascular diseases, malignancy, pregnancy, in acute intercurrent illness, congestive heart failure, myocardial infarction, received PCI or CABG. All subjects will receive EKG and CXR before randomization. These subjects will be randomized equally to 3 groups: acarbose, rosiglitazone and pioglitazone. The investigators will follow up for 6 months to investigate the short-term effects and 5 years to evaluate the long-term outcomes. The primary study end point of short-term study will be the macular thickness changes measured by optical coherence tomography, the changes in the level of urinary albumin-to-creatinine ratio, circulating metabolic parameters and adipocytokines during thiozolidinediones treatment. Secondary end point will be fasting blood glucose, A1C levels, development of clinically significant macular edema, serum creatinine change in patients with no history of diabetic retinopathy and nephropathy at baseline. The primary study end point of long-term study will be the development of clinically significant macular edema and the time from the base-line visit to the first detection of overt nephropathy. Secondary end points include the development of greater than moderate NPDR, the time to the first event of the time from the base-line visit to a doubling of the serum creatinine concentration, end-stage renal disease, or death.

Conditions

Diabetes

Keywords

thiazolidinediones; diabetes; retinopathy; nephropathy

Outcome Measures

Primary Outcomes (2)

• Diabetic retinopathy

  The macular thickness changes

  6 months

• Diabetic nephropathy

  The changes in the level of urinary albumin-to-creatinine ratio

  6 months

Secondary Outcomes (2)

• Diabetic retinopathy

  3 years

• Diabetic nephropathy

  3 years

Study Arms (2)

Actos

EXPERIMENTAL

Actos 30 mg for 6 months

Drug: Actos (Pioglitazone)

Acarbose

ACTIVE COMPARATOR

Acarbose 50mg tid for 6 months

Drug: Acarbose

Interventions

Actos (Pioglitazone) DRUG

Actos 30 mg for 6 months

Also known as: Pioglitazone

Actos

Acarbose DRUG

Acarbose 50 mg tid for 6 months

Also known as: Glucobay

Acarbose

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Age between 30-80 years old
• No significant nephropathy
• No significant retinopathy
• On submaximal dose of sulphonylureas and metformin treatment
• A1C between 7-9%

You may not qualify if:

• On insulin treatment
• Significant retinopathy (greater than moderate non-proliferative retinopathy)
• Significant nephropathy (overt proteinuria or serum Cr \>1.50 mg/dL)
• Malignancy
• Pregnancy
• Acute intercurrent illness
• Congestive heart failure (CHF, according to New York heart Association, NYHA functional class III to IV)
• Myocardial infarction, received PCI or CABG or liver cirrhosis

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital, Taiwan

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Chen YH, Tarng DC, Chen HS. Renal Outcomes of Pioglitazone Compared with Acarbose in Diabetic Patients: A Randomized Controlled Study. PLoS One. 2016 Nov 3;11(11):e0165750. doi: 10.1371/journal.pone.0165750. eCollection 2016.

  PMID: 27812149 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Retinal Diseases; Kidney Diseases

Interventions

Pioglitazone; Acarbose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Harn-Shen Chen, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harn-Shen Chen, MD, PhD

CONTACT

886-2-28757515; chenhs@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: August 4, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2015
• Last Updated: January 5, 2011

Record last verified: 2010-06

Locations

TW (1)