Status:
COMPLETED
PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs
Lead Sponsor:
University of Chile
Collaborating Sponsors:
Clinica Alemana de Santiago
Conditions:
DIABETES
DIABETIC RETINOPATHY
Eligibility:
All Genders
25-50 years
Phase:
PHASE4
Brief Summary
There is evidence of the association between diabetic microangiopathy and elevated serum concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with ingestion of specific...
Detailed Description
Patients: 6 adults with type 2diabetes will be selected, ages between 25 and 50 years, with more than 5 and less than 10 years of disease, adherent to treatment with oral hypoglycemic agents or insuli...
Eligibility Criteria
Inclusion
- TYPE 2 DIABETES
- More than 5 and less than 10 years of disease
- Adherent to treatment with oral hypoglycemic agents or insulin
- Agree to participate in the study through a written informed consent.
- High habitual intake of AGEs according the food recall .
Exclusion
- Severe Obesity (BMI\> 35 kg / m2)
- Glycosylated hemoglobin\> 9%, anemia, renal failure (creatinine\> 1.5 mg / dL or calculated creatinine clearance \<60 ml / min), fasting plasma glucose\> 250 mg / dL
- History of acute hyperglycemic complications requiring hospitalization in the past 2 years
- Severe diabetic dyslipidemia (LDL\> 130, TG\> 350 mg / dL)
- Vitamin B12 deficiency
- History of heart, liver, lung cancer or chronic diseases
- Clinical diagnosis of diabetic neiropathy and eye conditions that could hinder electroretinogram, such as uncorrected refractive defects, cataracts and severe diabetic retinopathy or macular edema.
- Poorly controlled hypertension or acute vascular event in the past 2 years
- Pregnancy.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02249897
Start Date
January 1 2015
End Date
December 1 2017
Last Update
February 14 2018
Active Locations (2)
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1
Institute of Nutrition & Food Technology (INTA)
Santiago, Metropolitan Region, Chile, 7830490
2
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile