Evidence map›Paper›PMID 37337229›Full record

ArticleTrials2023

Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial.

Xinyi Xia, Miao Xu, Yunjie Gu, Yangxue Li, Li Li, Jun Yin

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

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 87% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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 3 institutions in 1 country.

Xinyi Xia *Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Rd, Shanghai, 200233, China.
Miao Xu *Department of Endocrinology and Metabolism, Ningbo First Hospital, 59 Liuting Street, Ningbo, 315000, Zhejiang Province, China.
Yunjie GuDepartment of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Rd, Shanghai, 200233, China.
Yangxue LiDepartment of Endocrinology and Metabolism, Shanghai Eighth People's Hospital, 8 Caobao Road, Shanghai, 200235, China.
Li LiDepartment of Endocrinology and Metabolism, Ningbo First Hospital, 59 Liuting Street, Ningbo, 315000, Zhejiang Province, China. lilyningbo@163.com.
Jun YinDepartment of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Rd, Shanghai, 200233, China. yinjun@sjtu.edu.cn.ORCID http://orcid.org/0000-0002-9826-3583
Ningbo First Hospital · CNShanghai Eighth People Hospital · CNShanghai Sixth People's Hospital · CN

Funding

Medical Health Science and Technology Project of Zhejiang Province 2020KY255National Natural Science Foundation of China 81670790National Natural Science Foundation of China 82070885
6 · The paper itself

Abstract

backgroundLow-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In this study, we aim to compare the effects of LCD and canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with T2DM.

methodsThis is a multicenter, randomized controlled trial. We will recruit 120 patients with poor-controlled T2DM. Participants will be randomly divided into canagliflozin and LCD groups in a 1:1 ratio. The primary outcome is the change in hemoglobin A1C levels after the 3-month intervention. The secondary outcomes are the time in range and cost of antihyperglycemic agents. Exploratory outcomes include physical examination, body composition, glucose variability, appetite, glycolipid metabolism, liver lipid content, and urine glucose threshold. DISCUSSION: No previous study has compared an LCD with antihyperglycemic agents. In LoCaT, participants' metabolism will be assessed from multiple perspectives. It is believed that the finding obtained from this trial will optimize the treatments for patients with T2DM.

trial registrationChinese Clinical Trial Registry ChiCTR1900027592. Registered on November 20, 2019.

Indexed as

Diabetes Mellitus, Type 2Diet, Carbohydrate-RestrictedBlood GlucoseCanagliflozinHumansHypoglycemic AgentsMulticenter Studies as TopicRandomized Controlled Trials as TopicBlood GlucoseCanagliflozinHypoglycemic AgentsCanagliflozinLow-carbohydrate dietRandomized controlled trialStudy protocolType 2 diabetes mellitus

Identifiers

PMID37337229
PMCPMC10278275
OpenAlexW4381149442

What Socratic holds

Textfull text, public
LicenceCC BY
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Registered trials

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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 Socratic graph.