Evidence map›Paper›PMID 25774705›Full record

Trial reportItalian journal of pediatrics2015

Policaptil Gel Retard significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM.

Stefano Stagi, Elisabetta Lapi, Salvatore Seminara, Paola Pelosi, Paolo Del Greco, Laura Capirchio, Massimo Strano, Sabrina Giglio, Francesco Chiarelli, Maurizio de Martino

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Italian journal of pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.7field-weighted citation impact, top 14% 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.

NCT06813170 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes: Effect on Body Weight, in Vivo Oxidative Stress, Endothelial Function, Low-grade Inflammation and Gut Microbiota

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2025 to 2027Enrolled180ConditionsType 2 DiabetesArmsMetarecod, Diet
NCT07321184 phase4completednot on this mapstarted 2022, after this paper: background citation

Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.

TypeinterventionalSponsorUniversity of MilanRan2022 to 2024Enrolled36ConditionsChildhood ObesityArmsPolysaccharide-based complex
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 26 citations in OpenAlex.

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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.

Stefano Stagi
Elisabetta Lapi
Salvatore Seminara
Paola Pelosi
Paolo Del Greco
Laura Capirchio
Massimo Strano
Sabrina Giglio
Francesco Chiarelli
Maurizio de Martino
Meyer Children's Hospital · ITUniversity of Florence · ITUniversity of Chieti-Pescara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatments for childhood obesity are critically needed because of the risk of developing co-morbidities, although the interventions are frequently time-consuming, frustrating, difficult, and expensive. PATIENTS AND

methodsWe conducted a longitudinal, randomised, clinical study, based on a per protocol analysis, on 133 obese children and adolescents (n = 69 males and 64 females; median age, 11.3 years) with family history of obesity and type 2 diabetes mellitus (T2DM). The patients were divided into three arms: Arm A (n = 53 patients), Arm B (n = 45 patients), and Arm C (n = 35 patients) patients were treated with a low-glycaemic-index (LGI) diet and Policaptil Gel Retard, only a LGI diet, or only an energy-restricted diet (ERD), respectively. The homeostasis model assessment of insulin resistance (HOMA-IR) and the Matsuda, insulinogenic and disposition indexes were calculated at T0 and after 1 year (T1).

resultsAt T1, the BMI-SD scores were significantly reduced from 2.32 to 1.80 (p < 0.0001) in Arm A and from 2.23 to 1.99 (p < 0.05) in Arm B. Acanthosis nigricans was significantly reduced in Arm A (13.2% to 5.6%; p < 0.05), and glycosylated-haemoglobin levels were significantly reduced in Arms A (p < 0.005). The percentage of glucose-metabolism abnormalities was reduced, although not significantly. However, the HOMA-IR index was significantly reduced in Arms A (p < 0.0001) and B (p < 0.05), with Arm A showing a significant reduction in the insulinogenic index (p < 0.05). Finally, the disposition index was significantly improved in Arms A (p < 0.0001) and B (p < 0.05).

conclusionsA LGI diet, particularly associated with the use of Policaptil Gel Retard, may reduce weight gain and ameliorate the metabolic syndrome and insulin-resistance parameters in obese children and adolescents with family history of obesity and T2DM.

Indexed as

AdolescentChildComorbidityDiabetes Mellitus, Type 2FemaleGelsGlycemic IndexHumansHyperinsulinismMacromolecular SubstancesMaleObesityPediatric ObesityPolysaccharidesRisk FactorsTreatment OutcomeGelsMacromolecular SubstancesPolysaccharides

Identifiers

PMID25774705
PMCPMC4339082
OpenAlexW2164363898

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.