UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039979 |
|---|---|
| Receipt number | 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 | 2022/03/17 12:19:24 |
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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
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
okami@belle.shiga-med.ac.jp
Sponsor or person
Institute
Systematic Review Workshop Peer Support Group (SRWS-PSG)
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
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
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045533
