UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2022/03/17 (Ver. 3) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| 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 |
|
|
| Condition | |||
| Condition | Type 2 diabetes | ||
| Classification by specialty |
|
||
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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 |
|
||||||
| 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 |
|
||||||
| 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 | |
| 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 |
| 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 |
|
||||||
| 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 |
|
||||||
| Date of IRB |
|
||||||
| Anticipated trial start date |
|
||||||
| Last follow-up date |
|
||||||
| 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 |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045533 |
