Thiazolidinedione (TZD) on the Diabetic Retinopathy and Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01175486
First received: July 23, 2010
Last updated: January 4, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Actos (Pioglitazone)
Drug: Acarbose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Thiazolidinedione on the Diabetic Retinopathy and Nephropathy

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Diabetic retinopathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The macular thickness changes

  • Diabetic nephropathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The changes in the level of urinary albumin-to-creatinine ratio


Secondary Outcome Measures:
  • Diabetic retinopathy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Development of greater than moderate NPDR, clinically significant macular edema

  • Diabetic nephropathy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The change of urine albumin excretion, estimated GFR change, progression to overt diabetic nephropathy.


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Actos
Actos 30 mg for 6 months
Drug: Actos (Pioglitazone)
Actos 30 mg for 6 months
Other Name: Pioglitazone
Active Comparator: Acarbose
Acarbose 50mg tid for 6 months
Drug: Acarbose
Acarbose 50 mg tid for 6 months
Other Name: Glucobay

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175486

Contacts
Contact: Harn-Shen Chen, MD, PhD 886-2-28757515 chenhs@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital, Taiwan Recruiting
Taipei, Taiwan
Principal Investigator: Harn-Shen Chen, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Harn-Shen Chen, MD, PhD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Tung-Ping Su, Chairman, Institutional Review Board, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01175486     History of Changes
Other Study ID Numbers: 201004014IA
Study First Received: July 23, 2010
Last Updated: January 4, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
thiazolidinediones
diabetes
retinopathy
nephropathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Kidney Diseases
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Urologic Diseases
Vascular Diseases
2,4-thiazolidinedione
Acarbose
Pioglitazone
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 28, 2014