Dietary Polyphenols and Glycation in Renal Insufficiency

Diabetes Mellitus, Type 2 Clinical Trial

— PoGlyDRI  

Official title:

PoGlyDRI - Impact of Dietary Polyphenols on Protein Glycation in Type 2 Diabetes Mellitus Subjects With Chronic Renal Insufficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02524938
• Other study ID #: GN15DI242
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: September 2022

Study information

• Verified date: February 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and an increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may improve renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of the principle polyphenol groups in the diet - coffee/tea, stone fruits (especially plums/prunes) and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been associated with 25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure, and oxidative stress levels. This randomised controlled trial, therefore, aims to evaluate the effect of high CGA food on glycation and oxidative stress in T2DM subjects with early renal insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of renal insufficiency and the risk of cardiovascular diseases.

The study will have two phases - phase I, an interventional study of 3 months followed by phase II, an observational study of 21 months.

In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich food (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4 coffee cups per day) for 12 weeks. The control group will receive a conventional coffee low in chlorogenic acid.

Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At baseline, general information, medical history, dietary habits and medication use will be recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be collected and blood pressure, waist circumference, height and weight recorded. Participants' diet over the previous 3 days will be assessed by estimated food diary analysis.

In phase II, written dietary recommendations will be provided at three time points (months 6, 12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at least 1g per day, and at least 400mg per day of CGA) and standard dietary advice for the control group. Anthropometric/dietary data will be collected as well as blood and urine samples to assess markers of renal function, glycation and oxidative stress, and proteomic markers of cardiovascular disease, coronary artery disease and diabetes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• type 2 Diabetes Mellitus

• chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months

• fluent in English

Exclusion Criteria:

• dialysis therapy (current or previous)

• malignancy

• transplant recipient

• hyperthyroidism

• hypothyroidism

• high dose glucocorticoids (=250 mg)

• body mass index (BMI) = 45 kg/m2

• special dietary requirements

• take creatine, antioxidants or vitamin supplements

• smoker

• pregnant

• consume >4 cups of tea/coffee per day

• consume >5 portion of fruits and vegetables per day

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Chlorogenic Acid (CGA) enriched coffee
Chlorogenic Acid (CGA) enriched coffee Phase I: CGA-enriched coffee provided with a CGA content of 70-90 mg/100g. Daily CGA intake of 400mg. Phase II: recommendation for achieving a CGA-rich diet of at least 400mg/day (total polyphenol intake of at least 1g/day)
• Conventional coffee
Phase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	University of Glasgow	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycohaemoglobin (HbA1c)		3 months
Primary	Change in estimated glomerular filtration rate (eGFR)		21 months
Secondary	Change in fasting glucose		3 months
Secondary	Change in fructosamine		3 months
Secondary	Change in advanced glycation end product (AGE)		3 months
Secondary	Change in soluble receptor for AGE (sRAGE)		3 months
Secondary	Change in F2-isoprostane		3 months
Secondary	Change in malondialdehyde (MDA)		3 months
Secondary	Change in Urinary Albumin Excretion		21 months
Secondary	Change in creatinine		21 months
Secondary	Change in blood pressure		21 months
Secondary	Change in crystatin C		21 months
Secondary	Change in fibrinogen		21 months
Secondary	Change in cholesterol		21 months
Secondary	Change in C-reactive protein		21 months
Secondary	Change in Interleukin-6		21 months
Secondary	Change in thiobarbituric acid reactive substances (TBARS)		21 months
Secondary	Change in advanced oxidation protein products (AOPP)		21 months
Secondary	Change in 8hydroxy 2'deoxyguanoside (8OhdG)		21 months