Diabetic Nephropathy Type 2GlycotreatNCT03889236
Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.
A study testing Fasting mimicking diet Prolon and Food supplement Endocalyx in people with Diabetic Nephropathy Type 2 and Albuminuria, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy Type 2, Albuminuria, Type2 Diabetes Mellitus
- What is being tested?
- Fasting mimicking diet Prolon and Food supplement Endocalyx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 May 2018to 9 Sep 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- South Asian patient with diabetes mellitus type 2.
- Female or male, aged between 18 and 75 years.
- Body Mass Index ≥18.5.
- CKD-EPI >45 ml/min/1.73m² .
- Proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and <30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months.
- Systolic blood pressure ≤ 180 mmHg.
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- Treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin.
- Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
- Patients must be able to adhere to the study visit schedule and protocol requirements.
- If female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception.
- 4.3 Exclusion
Who cannot join
- Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
- Non-diabetic renal disease e.g. known polycystic kidney disease.
- Use of LMW heparin and/or immunosuppressive drugs.
- Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided.
- Signs of active infection or autoimmune disease, requiring systemic treatment.
- A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
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- Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- Use of any other investigational drug.
- Patient has enrolled another clinical trial within last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden Universitiy Medical Center (LUMC)
Leiden, North Holland
About this study
Official title: The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.
Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.
- Conditions
- Diabetic Nephropathy Type 2, Albuminuria, Type2 Diabetes Mellitus, Glucose Metabolism Disorders, Microalbuminuria, Diabetic Nephropathies
- Being tested
- Fasting mimicking diet Prolon, Food supplement Endocalyx, Placebo
- Medical subject headings
- Albuminuria, Glucose Metabolism Disorders, Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting mimicking diet ProlonOther
Also called FMD, Prolon, L-Nutra
5-day fasting mimicking diet
Food supplement EndocalyxDietary supplement
Also called Endocalyx, Q-prime
Food supplement
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Fasting mimicking diet | Experimental | 5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months. Receives: Other: Fasting mimicking diet Prolon |
| Food supplement | Experimental | 4 capsules a day of the food supplement Endocalyx for 3 months. Receives: Dietary Supplement: Food supplement Endocalyx |
| Placebo | Placebo comparator | 4 capsules a day of the placebo for 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
Measured: 3 months
Secondary outcomes (4)
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo
Measured: 3 months
Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo
Measured: 3 months
Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo
Measured: 3 months
Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start3 May 2018
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, Health Holland, Radboud University Medical Center
- Responsible party
- Principal investigator, AnoukvanderVelden, Leiden University Medical Center
- Investigators
- Ton J. Rabelink, Prof., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889236
- Sponsor's protocol ID
- P17.249
- Acronym
- Glycotreat
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Velden AIM, IJpelaar DHT, Chandie Shaw PK, Pijl H, Vink H, van der Vlag J, Rabelink TJ, van den Berg BM. Role of dietary interventions on microvascular health in South-Asian Surinamese people with type 2 diabetes in the Netherlands: A randomized controlled trial. Nutr Diabetes. 2024 Apr 10;14(1):17. doi: 10.1038/s41387-024-00275-5.
PubMed 38600065
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.
- ClinicalTrials.gov ID
- NCT03889236
- Acronym / sponsor ID
- Glycotreat / P17.249
- Conditions
- Diabetic Nephropathy Type 2, Albuminuria, Type2 Diabetes Mellitus, Glucose Metabolism Disorders, Microalbuminuria, Diabetic Nephropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, Health Holland, Radboud University Medical Center
- Study start
- 3 May 2018 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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.
Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
| Arm | Type | Receives |
|---|---|---|
| Fasting mimicking diet | Experimental | Other: Fasting mimicking diet Prolon5-day Fasting mimicking diet Prolon. In total 3 cycles of the FMD in three months. |
| Food supplement | Experimental | Dietary Supplement: Food supplement Endocalyx4 capsules a day of the food supplement Endocalyx for 3 months. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 capsules a day of the placebo for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- South Asian patient with diabetes mellitus type 2.
- Female or male, aged between 18 and 75 years.
- Body Mass Index ≥18.5.
- CKD-EPI >45 ml/min/1.73m² .
- Proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and <30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months.
Key exclusion criteria (9 listed)
- Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
- Non-diabetic renal disease e.g. known polycystic kidney disease.
- Use of LMW heparin and/or immunosuppressive drugs.
- Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided.
- Signs of active infection or autoimmune disease, requiring systemic treatment.
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 |
|---|---|---|
| Fasting mimicking diet ProlonAlso: FMD, Prolon, L-Nutra5-day fasting mimicking diet | Other | Fasting mimicking diet |
| Food supplement EndocalyxAlso: Endocalyx, Q-primeFood supplement | Dietary supplement | Food supplement |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
Time frame: 3 months
4 secondary outcomes
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo
Time frame: 3 months
Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo
Time frame: 3 months
Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo
Time frame: 3 months
Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 38600065van der Velden AIM, IJpelaar DHT, Chandie Shaw PK, Pijl H, Vink H, van der Vlag J, Rabelink TJ, van den Berg BM. Role of dietary interventions on microvascular health in South-Asian Surinamese people with type 2 diabetes in the Netherlands: A randomized controlled trial. Nutr Diabetes. 2024 Apr 10;14(1):17. doi: 10.1038/s41387-024-00275-5.
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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.
Ton J. Rabelink, Prof. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimicking diet Prolon and Food supplement Endocalyx in people with Diabetic Nephropathy Type 2 and Albuminuria, run by Leiden University Medical Center at 1 site in Netherlands.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889236, which also lists 1 linked publication.
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 18 Feb 2021.