Evidence map›Paper›PMID 30012185›Full record

ArticleTrials2018

Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial.

Mardin Rashid, Adrie J M Verhoeven, Monique T Mulder, Reinier Timman, Yvonne van Beek-Nieuwland, Athumani A Athumani, Adrienne A M Zandbergen, Hans E van der Wiel, Eric J G Sijbrands, Kirsten A Berk

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Mardin RashidDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Adrie J M VerhoevenDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Monique T MulderDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Reinier TimmanDepartment of Psychiatry, Section of Medical Psychology and Psychotherapy, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Yvonne van Beek-NieuwlandDepartment of Internal Medicine, Havenziekenhuis, Haringvliet 2, Rotterdam, 3011 TD, The Netherlands.
Athumani A AthumaniGeneral Practitioners Group, Stichting Zorg op Zuid, Maashaven Oostzijde 155, Rotterdam, 3072 HS, The Netherlands.
Adrienne A M ZandbergenDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Hans E van der WielDepartment of Internal Medicine, IJsselland Ziekenhuis, Prins Constantijnweg 2, Capelle aan de Ijssel, 2906 ZC, The Netherlands.
Eric J G SijbrandsDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Kirsten A BerkDepartment of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. k.berk@erasmusmc.nl.ORCID http://orcid.org/0000-0003-4097-4785
Erasmus MC · NLHavenziekenhuis Rotterdam · NLIJsselland Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications. Monomeric and oligomeric flavanols (MOF) isolated from grape seeds (Vitis vinifera) have been linked to improved endothelial function and vascular health. The aim of this study is to determine the effect of a daily supplementation of 200 mg MOF on renal endothelial function of patients with T2D and microalbuminuria. METHODS/

designFor this double-blind, placebo-controlled, randomized, multicenter trial 96 individuals (ages 40-85 years) with T2D and microalbuminuria will be recruited. Participants will be randomly assigned to the intervention group, receiving 200 mg of MOF daily for 3 months, or to the control group, receiving a placebo. The primary endpoint is the evolution over time in albumin excretion rate (AER) until 3 months of intervention as compared with placebo. Secondary endpoints are the evolution over time in established plasma markers of renal endothelial function-asymmetric dimethylarginine (ADMA), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intercellular cell adhesion molecule-1 (sICAM-1), interleukin-6 (IL-6), and von Willebrand Factor (vWF)-until 3 months of intervention as compared with placebo. Mixed modeling will be applied for the statistical analysis of the data. DISCUSSION: We hypothesize that T2D patients with microalbuminuria have a medically determined requirement for MOF and that fulfilling this requirement will result in a decrease in AER and related endothelial biomarkers. If confirmed, this may lead to new insights in the dietary management of patients with T2D.

trial registrationNederlands Trial Register, NTR4669 , registered on 7 July 2014.

Indexed as

Randomized Controlled Trials as TopicAdultAgedAged, 80 and overAlbuminuriaData Interpretation, StatisticalDiabetes Mellitus, Type 2Double-Blind MethodFlavonolsHumansMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health CareSample SizeSeedsVitisFlavonolsMicroalbuminuriaMonomeric flavanolsOligomeric flavanolsType 2 diabetes mellitus

Identifiers

PMID30012185
PMCPMC6048822
OpenAlexW2883083048

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.