Evidence map›Paper›PMID 30574667›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2019

Study Protocol for the Effects of Formula Diet with Dapagliflozin on Metabolic Improvement and Body Composition in Type 2 Diabetes Mellitus.

Yasuhiro Watanabe, Nobuichi Kuribayashi, Daigaku Uchida, Daisuke Suzuki, Mitsutoshi Kato, Daiji Nagayama, Hiroshi Ohashi, Masahiro Ohira, Atsuhito Saiki, Ichiro Tatsuno

Erratum issuedOpen 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 34% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Yasuhiro WatanabeCenter of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Chiba, Japan.
Nobuichi KuribayashiMisaki Naika Clinic, Chiba, Japan.
Daigaku UchidaHotaruno Central Naika, Chiba, Japan.
Daisuke SuzukiSuzuki Diabetes Clinic, Kanagawa, Japan.
Mitsutoshi KatoKato Clinic of Internal Medicine, Tokyo, Japan.
Daiji NagayamaNagayama Clinic, Tochigi, Japan.
Hiroshi OhashiOyama East Clinic, Tochigi, Japan.
Masahiro OhiraCenter of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Chiba, Japan.
Atsuhito SaikiCenter of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Chiba, Japan.
Ichiro TatsunoCenter of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Chiba, Japan. ichiro.tatsuno@med.toho-u.ac.jp.
Toho University · JPToho University Medical Center Sakura Hospital · JPSubaru (Japan) · JPSuzuki (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSodium-dependent glucose transporter-2 (SGLT2) inhibitors such as dapagliflozin induce weight loss, but the mechanism is thought to involve loss of both body fat and skeletal muscle mass. The decrease in skeletal muscle mass may lead to worsening of insulin resistance in type 2 diabetes patients. On the other hand, formula diet (FD) is a low-calorie food containing low carbohydrates, low fat, and sufficient protein, vitamins, and minerals to support a healthy and balanced diet, and is used for the treatment of obesity or diabetes. Therefore, we examine whether the protein supplementation is superior to the fat supplementation in metabolic improvement of the poorly controlled type 2 diabetes patients treated with SGLT2 inhibitor. We compare the therapeutic effects using two types of FD; a high protein FD and a high fat FD. Patients are prescribed dapagliflozin and replacement of one of three meals with FD. We compare high protein FD and high fat FD with respect to improvement of glycemic control while maintaining skeletal muscle mass.

methodsWe conduct a prospective, multicenter, double-blinded, randomized, controlled, investigator-initiated clinical trial. Patients who satisfy the eligibility criteria will be randomized to two groups (1:1) and prescribed 5 mg of dapagliflozin once daily together with a high protein FD or high fat FD (same number of calories) to replace one of three meals a day (one meal with FD only and two normal meals). The observation period for both groups is 24 weeks. The primary endpoint is the change in HbA1c. PLANNED OUTCOMES: This study is ongoing and scheduled to complete in June 2019. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.

trial registrationUniversity Hospital Medical Information Network (UMIN) 000024580.

fundingThis study was carried out under contract with the specified nonprofit corporation Hokkaido Institute of Health Sciences, based on a grant from AstraZeneca Co., Ltd. and Ono Pharmaceutical Co., Ltd. for an investigator-initiated clinical trial. The authors funded the journals article processing charges.

Indexed as

Body compositionDapagliflozinDiabetesFormula dietSkeletal muscle

Identifiers

PMID30574667
PMCPMC6349273
OpenAlexW4255911888

What OpenQuestion holds

Textmetadata
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.