UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018513
Receipt No. R000021427
Scientific Title Major Increases in Morning Glucose Levels May Predict Nocturnal Hypoglycemia in Type 2 Diabetes -retrospective study-
Date of disclosure of the study information 2015/07/31
Last modified on 2015/07/31

* 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 Major Increases in Morning Glucose Levels May Predict Nocturnal Hypoglycemia in Type 2 Diabetes -retrospective study-
Acronym Increases glucose predict hypoglycemia.
Scientific Title Major Increases in Morning Glucose Levels May Predict Nocturnal Hypoglycemia in Type 2 Diabetes -retrospective study-
Scientific Title:Acronym Increases glucose predict hypoglycemia.
Region
Japan

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

Objectives
Narrative objectives1 Nocturnal hypoglycemia may be associated with increased morning glucose levels; however, the mechanism of this relationship remains unknown.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pre-breakfast glucose level, highest postprandial glucose level within 3 h after breakfast, time from start of breakfast to the highest postprandial glucose level, difference between pre-breakfast and highest postprandial breakfast glucose levels, area under the curve (AUC) (180 mg/dL) for glycemic variability within 3 h after breakfast, post-breakfast glucose gradient, and the increased glucose level/pre-breakfast glucose level ratio were calculated. We analyzed the associations between these factors and nocturnal hypoglycemia (<70 mg/dL from 0:00 to 8:00) using logistic regression analysis. ROC analysis was used to determine optimal cut-off values to predict nocturnal hypoglycemia.
Key secondary outcomes

Base
Study type Observational

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria type 2 diabetes who underwent continuous glucose monitoring (CGM) during admission.
Key exclusion criteria take glucose
take alpha-GI
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization Ichinomiyanishi Hospital
Division name Department of Endocrinology and Diabetes
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001
TEL 0586-48-0077
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization Ichinomiyanishi Hospital
Division name Department of Endocrinology and Diabetes
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001
TEL 0586-48-0077
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Ichinomiyanishi Hospital
Institute
Department

Funding Source
Organization Ichinomiyanishi Hospital
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
Address
Tel
Email

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
2015 Year 07 Month 31 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
2015 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively analyzed 106 patients with type 2 diabetes who underwent continuous glucose monitoring (CGM) during admission. Pre-breakfast glucose level, highest postprandial glucose level within 3 h after breakfast, time from start of breakfast to the highest postprandial glucose level, difference between pre-breakfast and highest postprandial breakfast glucose levels, area under the curve (AUC) (180 mg/dL) for glycemic variability within 3 h after breakfast, post-breakfast glucose gradient, and the increased glucose level/pre-breakfast glucose level ratio were calculated. We analyzed the associations between these factors and nocturnal hypoglycemia (<70 mg/dL from 0:00 to 8:00) using logistic regression analysis. ROC analysis was used to determine optimal cut-off values to predict nocturnal hypoglycemia.

Management information
Registered date
2015 Year 07 Month 31 Day
Last modified on
2015 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.