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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039979
Receipt No. R000045533
Scientific Title The effect of meal sequence on diabetes improvement in patients with type 2 diabetes: a systematic review and meta-analysis (protocol).
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/28

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Basic information
Public title The effect of meal sequence on diabetes improvement in patients with type 2 diabetes: a systematic review and meta-analysis (protocol).
Acronym The effect of meal sequence on diabetes improvement in patients with type 2 diabetes: a systematic review and meta-analysis (protocol).
Scientific Title The effect of meal sequence on diabetes improvement in patients with type 2 diabetes: a systematic review and meta-analysis (protocol).
Scientific Title:Acronym The effect of meal sequence on diabetes improvement in patients with type 2 diabetes: a systematic review and meta-analysis (protocol).
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To review systematically the evidence to identify the effect of meal sequence on the improvement of diabetes for type 2 diabetes patients.
Basic objectives2 Others
Basic objectives -Others N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.HbA1c(NGSP)
follow up: range 3 months to 2 years
2. Physical component summary score (SF36,SF12,SF8)
Scale from: 0 to 100
follow up: range 3 months to 2 years
3. Mental component summary score (SF36,SF12,SF8)
Scale from: 0 to 100
follow up: range 3 months to 2 years
Key secondary outcomes 4. Plasma glucose after 120 min of meal
5. Plasma insulin after 120 min of meal
6. Plasma incretin (GLP-1(glucagon-like peptide-1), GIP(glucose-dependent insulinotropic polypeptide)) after 120 min of meal
7. All adverse events
The percentage of the adverse events (follow the authors' definition)
follow up: range 3 months to 2 years

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients
Both males and females
All ages
Key exclusion criteria Type 1 diabetes patients
Patients after surgery (ex.gastric resection)
Target sample size 0

Research contact person
Name of lead principal investigator
1st name Yukiko
Middle name
Last name Okami
Organization Shiga University of Medical Science
Division name Department of Public Health
Zip code 520-2192
Address Tsukinowa, Seta, Otsu, Shga, JAPAN, 520-2192
TEL 077-548-2476
Email okami@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Yukiko
Middle name
Last name Okami
Organization Shiga University of Medical Science
Division name Department of Public Health
Zip code 520-2192
Address Tsukinowa, Seta, Otsu, Shga, JAPAN, 520-2192
TEL 077-548-2476
Homepage URL
Email okami@belle.shiga-med.ac.jp

Sponsor
Institute Systematic Review Workshop Peer Support Group (SRWS-PSG)
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Public Health, Shiga University of Medical Science
Address Tsukinowa, Seta, Otsu, Shiga, JAPAN
Tel 077-548-2476
Email okami@belle.shiga-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Research Methods
1-1. Inclusion criteria
All published and pre-published randomized controlled trials (RCTs), including individual RCTs, cluster RCTs, cross over RCTs.
All languages and countries.
1-2. Exclusion criteria
Non-RCTs

2. Search Methods
2-1. Electronic search (the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, EMBASE via ProQuest)
2-2 Other resources (the World Health Organization International Clinical Trials Platform Search Portal (ICTRP), ClinicalTrials.gov)

3. Bias risk
Two reviewers will conduct the study independently using the Risk of Bias 2 tool. Disagreements between the two reviewers will be discussed and resolved by the two of them. Discuss with a third reviewer, if necessary.

4. Evaluation of treatment effects
Meta-analysis of standardized mean difference (SMD) and 95% CIs for the following continuous variables: HbA1c concentrations, Physical component summary score, Mental component summary score, Plasma glucose, Plasma insulin, Plasma incretin.
Adverse events will be summarized according to the definitions of each study.

5. Subgroup analysis and the search for heterogeneity
(For P) Stratified analysis by gender.
(For I) Limit the type of staple food to rice only. Limit non-staple foods to vegetables, fatty foods, or protein only.

6. Sensitivity analysis
6-1. Exclusion of studies using imputed statistics.
6-2. Missing participants: Verify the robustness of the results by seeking informative missingness odds ratios.

7. Summary of findings Table
SOF tables will be created for the following outcomes.
Primary outcomes
1. HbA1c concentrations (NGSP)
2. Physical component summary score (SF36, SF12, SF8)
3. Mental component summary score (SF36, SF12, SF8)
Secondary outcomes
4. Plasma glucose after 120 min of meal
5. Plasma insulin after 120 min of meal
6. Plasma incretin (GLP-1, GIP) after 120 min of meal
7. All adverse events

Management information
Registered date
2020 Year 03 Month 30 Day
Last modified on
2020 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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