PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02249897
• Date of registration: 17/09/2014
• Prospective Registration: Yes
• Primary sponsor: University of Chile
• Public title: PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs PREL-AGES
• Scientific title: PRELIMINARY EVALUATION OF RETINAL EFFECTS OF PHARMACOLOLOGICAL LOWERING OF SERUM LEVES OF ADVANCED GLYCATION END-PRODUCTS (AGEs) IN TYPE 2 DIABETIC PATIENTS
• Date of first enrolment: January 2015
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02249897
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Chile

Contacts

• Name: MARIA PIA DE LA MAZA, PROFESSOR
• Affiliation: INSTITUTE OF NUTRITION & FOOD TECHNOLOGY, UNIVERSITY OF CHILE

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 25 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

DIABETIC NEUROPATHY

DIABETIC RETINOPATHY

DIABETES

Intervention(s)

Drug: CHOLESTYRAMINE

Primary Outcome(s)

CML SERUM LEVELS [Time Frame: 12 WEEKS]

Secondary Outcome(s)

MULTIFOCAL ELECTRORETINOGRAPHY [Time Frame: 12 WEEKS]

OPTICAL NERVE CONDUCTION [Time Frame: 12 WEEKS]

Secondary ID(s)

AGE-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinica Alemana de Santiago