Evidence map›Paper›PMID 38494571›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2024

Evaluating the Safety and Efficacy of Sodium-Glucose Co-transporter 2 Inhibitors in Subjects with Prediabetes: A Protocol for a Randomized Controlled Trial.

Xiaxuan Zhu, Li Xia, Deshan Yin, Jin Yang, Rui Wei

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05914857. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT05914857 phase2unknown status

Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients: A Randomized Trial

Ran2023Enrolled120Registered outcomes9Posted comparisons0ConditionsImpaired Fasting Glucose, Impaired Glucose Tolerance, Prediabetic StateArmsDapagliflozin 10mg Tab, lifestyle interventions
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

5 authors at 1 institution in 1 country.

Xiaxuan Zhu *Department of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Li Xia *Department of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Deshan YinDepartment of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Jin YangDepartment of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Rui WeiDepartment of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China. weirui@bjmu.edu.cn.ORCID http://orcid.org/0000-0002-8838-703X
Peking University · CN

Funding

Key Technologies Research and Development Program 2022YFC2702600
6 · The paper itself

Abstract

introductionPrediabetes is a state of subclinical glycemic impairment, bridging normal glucose tolerance and diabetes. Globally, over 30% of individuals exhibit prediabetic conditions, with a significant proportion progressing to diabetes. Prediabetes augments risks of various diseases including cardiovascular and kidney disease. While interventions like lifestyle changes have shown promise in diabetes prevention, their long-term sustainability is challenging. Alternative pharmacological treatments, such as acarbose and metformin, have demonstrated efficacy in certain populations. Sodium-glucose co-transporter 2 inhibitors, a novel class of glucose-lowering agents, have shown potential benefits for heart and kidney health in patients with diabetes. This research aims to evaluate the effectiveness and safety of dapagliflozin in individuals with prediabetes, elucidating its potential role in diabetes prevention strategies. RESEARCH DESIGN AND

methodsThis prospective trial is being conducted at Peking University Third Hospital. A total of 240 participants with prediabetes will be enrolled and randomly divided into two groups: one receiving dapagliflozin (10 mg/day) with lifestyle education, and the other with lifestyle education alone over a 12-week duration (with male/female = 1:1 in each group). Anthropometric, clinical and laboratory tests, including body mass index, waist circumference, fasting blood glucose, oral glucose tolerance test, insulin, lipid profile, liver and kidney function, sperm quality, will be conducted at the onset and conclusion of the trial. For adherence monitoring, participants will receive phone follow-ups at week 4 and week 8. The primary outcome is the change in 2-h plasma glucose during an oral glucose tolerance test over the study duration. Secondary outcomes encompass changes in various health metrics, including body mass index, lipid profiles, and liver function. PLANNED OUTCOMES: The proposed study is set to refine diabetes prevention strategies on the basis of its potential benefits observed in patients with diabetes.

conclusionsThis will be the first randomized controlled trial to evaluate the safety and effectiveness of sodium-glucose co-transporter 2 inhibitors compared with lifestyle education for individuals with prediabetes.

trial registrationClinicalTrials.gov identifier NCT05914857 (registered 24 July 2023).

Indexed as

PrediabetesPrediabetes managementSodium-glucose co-transporter 2 inhibitors

Identifiers

PMID38494571
PMCPMC11043312
OpenAlexW4392922598

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.