UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of the muscle/fat mass ratio with insulin resistance in gestational diabetes mellitus
Title of the study (Brief title)	Muscle mass and insulin resistance in GDM
Region	Japan

Condition
Condition	gestational diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Obsterics 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	Yasushi Tanaka
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL	0449778111
Email	ynagai@marianna-u.ac.jp

Public contact
Name of contact person	Yoshio Nagai
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan
TEL	0449778111
Homepage URL
Email	ynagai@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037790