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The Relationship Between Advanced Glycation Endproducts and Diabetes

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ClinicalTrials.gov Identifier: NCT02662010
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The overall purpose of this COMIRB application is to perform a cross-sectional pilot study to aid in the design of a prospective epidemiologic study for an NIH grant application. The long term goal of this research is to determine if AGEs are predictors of glycemic control and the development of diabetic retinopathy in patients with T2DM. Understanding these relationships could lead to a prospective prediction of the onset/worsening of diabetic retinopathy in T2DM patients and in pre-diabetic individuals.

Condition or disease
Diabetic Retinopathy Type 2 Diabetes Mellitus

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Relationship of Advanced Glycation Endproducts in the Anterior Lens Capsule to Glycemic Status and Diabetic Retinopathy: A Cross Sectional Study of Patients With and Without Type 2 Diabetes Mellitus Undergoing Cataract Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Advanced Glycation Endproducts (AGE) Levels [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change in HbA1C Levels [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Buffy Coat


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Investigators propose recruiting 80 subjects (40 with no diabetes, 20 with diabetes and no diabetic retinopathy and 20 with diabetes and diabetic retinopathy).

Within the 40 control patients without a clinical diagnosis of T2DM, 20 will have an abnormal HbA1C at the time of surgery. It is important to enroll the patients with an abnormal HbA1C in order to see if there are early manifestations of an abnormal glucose level as detected by AGEs in the anterior lens capsule.

Criteria

Inclusion criteria (cases):

  • T2DM as documented by the referring physician, an HbA1C level of greater than 5.7 mmol/mol, or on T2DM medications beyond Metformin.
  • 50% of the cases will have diabetic retinopathy as documented by the attending ophthalmologist and 50% will have no retinopathy.
  • Age 60-80 years old.

Inclusion criteria (controls):

  1. Normal HbA1C

    • No diabetes as documented by the referring physician, a HbA1C level of less than or equal to 5.7 mmol/mol, or not taking medications for T2DM with the exception of Metformin.
    • Age 60-80 years old.
  2. Abnormal HbA1C

    • No diabetes as documented by the referring physician, a HbA1C level between 5.7 and 6.5 mmol/mol, and not taking medications for T2DM with the exception of Metformin.
    • Age 60-80 years old.

Exclusion criteria (cases):

  • Type 1 diabetes as documented by the referring physician.
  • <60 years old or >80 years old.
  • If the patient has bilateral cataract surgery, the second surgery will be excluded
  • Patients who have active cancer, being treated (receiving Chemotherapy or Radiation therapy) or disseminated, recent CVD event, MI or CVA within 6 months, and disease related weight loss of more than 10% in the past 3-6 months.

Exclusion criteria (controls):

  • Type 1 or T2DM as documented by the referring physician.
  • <60 years old or >80 years old.
  • No treatment with Metformin or modifiers for risk of T1DM
  • If the patient has bilateral cataract surgery, the second surgery will be excluded
  • Patients who have active cancer, being treated (receiving Chemotherapy or Radiation therapy) or disseminated, recent CVD event, MI or CVA within 6 months, and disease related weight loss of more than 10% in the past 3-6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662010


Contacts
Contact: Levi Bonnell 3038483059 levi.bonnell@ucdenver.edu

Locations
United States, Colorado
Universtiy of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Levi Bonnell, MPH    303-848-5039    levi.bonnell@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Ram Nagaraj, PhD University of Colorado School of Medicine

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02662010     History of Changes
Other Study ID Numbers: 15-2029
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
AGEs
glycemic control
T2DM

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Diabetic Angiopathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications