Diabetes Mellitus, Type 2PoGlyDRINCT02524938
Dietary Polyphenols and Glycation in Renal Insufficiency
A study testing Chlorogenic Acid (CGA) enriched coffee and Conventional coffee in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
- What is being tested?
- Chlorogenic Acid (CGA) enriched coffee and Conventional coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2016to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 Diabetes Mellitus
- chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months
- fluent in English
Who cannot join
- dialysis therapy (current or previous)
- malignancy
- transplant recipient
- hyperthyroidism
- hypothyroidism
- high dose glucocorticoids (≥250 mg)
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Greater Glasgow and Clyde
Glasgow
University of Glasgow
Glasgow
About this study
Official title: PoGlyDRI - Impact of Dietary Polyphenols on Protein Glycation in Type 2 Diabetes Mellitus Subjects With Chronic Renal Insufficiency
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.
Read more
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.
- Being tested
- Chlorogenic Acid (CGA) enriched coffee, Conventional coffee
- Keywords
- Dietary polyphenols, Protein glycation
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorogenic Acid (CGA) enriched coffeeDietary supplement
Also called CGA-enriched diet
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 coffeeDietary supplement
Also called Habitual diet
Phase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Chlorogenic Acid (CGA) 400mg/day (CGA-enriched coffee) Receives: Dietary Supplement: Chlorogenic Acid (CGA) enriched coffee |
| Control group | Sham comparator | Conventional coffee (habitual diet) Receives: Dietary Supplement: Conventional coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycohaemoglobin (HbA1c)
Measured: 3 months
Change in estimated glomerular filtration rate (eGFR)
Measured: 21 months
Secondary outcomes (17)
Change in fasting glucose
Measured: 3 months
Change in fructosamine
Measured: 3 months
Change in advanced glycation end product (AGE)
Measured: 3 months
Change in soluble receptor for AGE (sRAGE)
Measured: 3 months
Change in F2-isoprostane
Measured: 3 months
Change in malondialdehyde (MDA)
Measured: 3 months
Change in Urinary Albumin Excretion
Measured: 21 months
Change in creatinine
Measured: 21 months
Change in blood pressure
Measured: 21 months
Change in crystatin C
Measured: 21 months
Change in fibrinogen
Measured: 21 months
Change in cholesterol
Measured: 21 months
Change in C-reactive protein
Measured: 21 months
Change in Interleukin-6
Measured: 21 months
Change in thiobarbituric acid reactive substances (TBARS)
Measured: 21 months
Change in advanced oxidation protein products (AOPP)
Measured: 21 months
Change in 8hydroxy 2'deoxyguanoside (8OhdG)
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start1 Jun 2016
- Primary completionSep 2022
- Study completionSep 2022
Why it stopped: Failure to recruit due to human resourcing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Emilie Combet, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524938
- Sponsor's protocol ID
- GN15DI242
- Acronym
- PoGlyDRI
- Status last verified
- Feb 2023
- First submitted
- 14 Jul 2015
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PoGlyDRI - Impact of Dietary Polyphenols on Protein Glycation in Type 2 Diabetes Mellitus Subjects With Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT02524938
- Acronym / sponsor ID
- PoGlyDRI / GN15DI242
- Keywords
- Dietary polyphenols, Protein glycation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit due to human resourcing
- Enrolment
- 9 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Chlorogenic Acid (CGA) enriched coffeeChlorogenic Acid (CGA) 400mg/day (CGA-enriched coffee) |
| Control group | Sham comparator | Dietary Supplement: Conventional coffeeConventional coffee (habitual diet) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 Diabetes Mellitus
- chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months
- fluent in English
Key exclusion criteria (13 listed)
- dialysis therapy (current or previous)
- malignancy
- transplant recipient
- hyperthyroidism
- hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorogenic Acid (CGA) enriched coffeeAlso: CGA-enriched dietChlorogenic 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) | Dietary supplement | Treatment group |
| Conventional coffeeAlso: Habitual dietPhase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice | Dietary supplement | Control group |
Primary outcome
Change in glycohaemoglobin (HbA1c)
Time frame: 3 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: 21 months
17 secondary outcomes
Change in fasting glucose
Time frame: 3 months
Change in fructosamine
Time frame: 3 months
Change in advanced glycation end product (AGE)
Time frame: 3 months
Change in soluble receptor for AGE (sRAGE)
Time frame: 3 months
Change in F2-isoprostane
Time frame: 3 months
Change in malondialdehyde (MDA)
Time frame: 3 months
Change in Urinary Albumin Excretion
Time frame: 21 months
Change in creatinine
Time frame: 21 months
Change in blood pressure
Time frame: 21 months
Change in crystatin C
Time frame: 21 months
Change in fibrinogen
Time frame: 21 months
Change in cholesterol
Time frame: 21 months
Change in C-reactive protein
Time frame: 21 months
Change in Interleukin-6
Time frame: 21 months
Change in thiobarbituric acid reactive substances (TBARS)
Time frame: 21 months
Change in advanced oxidation protein products (AOPP)
Time frame: 21 months
Change in 8hydroxy 2'deoxyguanoside (8OhdG)
Time frame: 21 months
Results and safety
The study was stopped early (reason given: Failure to recruit due to human resourcing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Combet, PhD principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorogenic Acid (CGA) enriched coffee and Conventional coffee in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit due to human resourcing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycohaemoglobin (HbA1c) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.