The Relationship Between Advanced Glycation Endproducts and Diabetes

NCT02662010 | Completed DMC

• 2 other identifiers: 15-2029UL1TR001082
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Type 2 Diabetes Mellitus

Keywords

AGEs; glycemic control; T2DM

Outcome Measures

Primary Outcomes (1)

• Change in Advanced Glycation Endproducts (AGE) Levels

  1 year

Secondary Outcomes (1)

• Change in HbA1C Levels

  1 year

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Universtiy of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (7)

• Milne R, Brownstein S. Advanced glycation end products and diabetic retinopathy. Amino Acids. 2013 Jun;44(6):1397-407. doi: 10.1007/s00726-011-1071-3. Epub 2011 Sep 11.

  PMID: 21909978 BACKGROUND

• Ulrich P, Cerami A. Protein glycation, diabetes, and aging. Recent Prog Horm Res. 2001;56:1-21. doi: 10.1210/rp.56.1.1.

  PMID: 11237208 BACKGROUND

• Yan SF, D'Agati V, Schmidt AM, Ramasamy R. Receptor for Advanced Glycation Endproducts (RAGE): a formidable force in the pathogenesis of the cardiovascular complications of diabetes & aging. Curr Mol Med. 2007 Dec;7(8):699-710.

  PMID: 18331228 BACKGROUND

• Nowotny K, Jung T, Hohn A, Weber D, Grune T. Advanced glycation end products and oxidative stress in type 2 diabetes mellitus. Biomolecules. 2015 Mar 16;5(1):194-222. doi: 10.3390/biom5010194.

  PMID: 25786107 BACKGROUND

• Monnier VM, Sell DR, Genuth S. Glycation products as markers and predictors of the progression of diabetic complications. Ann N Y Acad Sci. 2005 Jun;1043:567-81. doi: 10.1196/annals.1333.065.

  PMID: 16037280 BACKGROUND

• Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.

  PMID: 21030723 BACKGROUND

• Smuda M, Henning C, Raghavan CT, Johar K, Vasavada AR, Nagaraj RH, Glomb MA. Comprehensive analysis of maillard protein modifications in human lenses: effect of age and cataract. Biochemistry. 2015 Apr 21;54(15):2500-7. doi: 10.1021/bi5013194. Epub 2015 Apr 7.

  PMID: 25849437 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buffy Coat

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ram Nagaraj, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: March 1, 2016
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)