UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033137 |
|---|---|
| Receipt number | R000037790 |
| Scientific Title | Association of the muscle/fat mass ratio with insulin resistance in gestational diabetes mellitus |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/25 15:30:22 |
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Basic information
Public title
Association of the muscle/fat mass ratio with insulin resistance in gestational diabetes mellitus
Acronym
Muscle mass and insulin resistance in GDM
Scientific Title
Association of the muscle/fat mass ratio with insulin resistance in gestational diabetes mellitus
Scientific Title:Acronym
Muscle mass and insulin resistance in GDM
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association of muscle mass with insulin resistance, evaluated from the insulin sensitivity index (ISI), in Japanese patients with gestational diabetes mellitus (GDM).
Basic objectives2
Others
Basic objectives -Others
The relationship between daily activity assessed by IPAQ and muscle mass
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the association of muscle mass with insulin resistance
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
women with at least one elevated glucose value based upon the IADPSG criteria (fasting>92 mg/dL, 1h>180 mg/dL, or 2h>153 mg/dL) were classified as having GDM.
Key exclusion criteria
The exclusion criteria were as follows: (i) non-singleton pregnancy, (ii) overt diabetes, (iii) a past history of diabetes, (iv) severe infection, (v) patients before/after surgery, (vi) and patients with preeclampsia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL
0449778111
ynagai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Nagai |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL
0449778111
Homepage URL
ynagai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
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
| 2018 | Year | 07 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On the day after hospitalization, each patient underwent a 5-point 75-g OGTT with measurement of plasma glucose and serum insulin levels. To evaluate insulin resistance, we calculated the insulin sensitivity index (ISI) from the OGTT data according to the following formula: ISI = 10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during the OGTT]). Then body composition was measured after urination and before lunch by using the MC-190EM Body Composition Analyzer (Tanita Corp., Tokyo, Japan) according to the manufacturer's instructions.
Management information
Registered date
| 2018 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037790
