Evidence map›Paper›PMID 23585665›Full record

ArticleThe Journal of clinical endocrinology and metabolism2013

Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus.

David Polidori, Sue Sha, Atalanta Ghosh, Leona Plum-Mörschel, Tim Heise, Paul Rothenberg

Open access · bronzeAbstract readControlled Clinical TrialValidation Study
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 1% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.

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  9. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus.The Journal of clinical endocrinology and metabolism · 2016
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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

6 authors at 2 institutions in 2 countries.

David PolidoriJanssen Research & Development, LLC, 3210 Merryfield Row, San Diego, CA 92121, USA. DPolido1@its.jnj.com
Sue Sha
Atalanta Ghosh
Leona Plum-Mörschel
Tim Heise
Paul Rothenberg
Janssen (United States) · USProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextThe stepwise hyperglycemic clamp procedure (SHCP) is the gold standard for measuring the renal threshold for glucose excretion (RT(G)), but its use is limited to small studies in specialized laboratories.

objectiveThe objective of the study was to validate a new method for determining RT(G) using data obtained during a mixed-meal tolerance test (MMTT) in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus (T2DM).

designThis was an open-label study with 2 sequential parts.

settingThe study was performed at a single center in Germany. PATIENTS: Twenty-eight subjects with T2DM were studied.

interventionsNo treatment intervention was given in part 1. In part 2, subjects were treated with canagliflozin 100 mg/d for 8 days. In each part, subjects underwent an MMTT and a 5-step SHCP on consecutive days.

main outcome measuresFor both methods, RT(G) was estimated using measured blood glucose (BG) and urinary glucose excretion (UGE); estimated glomerular filtration rates were also used to determine RT(G) during the MMTT. The methods were compared using the concordance correlation coefficient and geometric mean ratios.

resultsIn untreated and canagliflozin-treated subjects, the relationship between UGE rate and BG was well described by a threshold relationship. Good agreement was obtained between the MMTT-based and SHCP-derived RT(G) values. The concordance correlation coefficient (for all subjects) was 0.94; geometric mean ratios (90% confidence intervals) for RT(G) values (MMTT/SHCP) were 0.93 (0.89-0.96) in untreated subjects and 1.03 (0.78-1.37) in canagliflozin-treated subjects. Study procedures and treatments were generally well tolerated in untreated and canagliflozin-treated subjects.

conclusionsIn both untreated and canagliflozin-treated subjects with T2DM, RT(G) can be accurately estimated from measured BG, UGE, and estimated glomerular filtration rates using an MMTT-based method.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsBlood GlucoseBody Mass IndexCanagliflozinDiabetes Mellitus, Type 2FemaleGlomerular Filtration RateGlucosidesGlycosuriaHumansHyperglycemiaHypoglycemic AgentsKidneyKidney Function TestsMaleMembrane Transport ModulatorsBlood GlucoseCanagliflozinGlucosidesHypoglycemic AgentsMembrane Transport ModulatorsSodium-Glucose Transporter 2 InhibitorsThiophenes

Identifiers

PMID23585665
PMCPMC3706739
OpenAlexW2135097670

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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.