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The Impact of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Former Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
vitamin D
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Gestational diabetes mellitus, vitamin D, postpartum

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. with previous GDM,40-50 days after birth -
  2. with deficiency of vitamin D(25-(OH)D3<50nmol/L)

Exclusion Criteria:

  1. type 1 diabetes,type 2 diabetes and other type of diabetes
  2. server disfunction of liver and kidney(ALT >100U/L,Cr>132ummol/L)
  3. with mental disease,sever anemia,sever infection,sever heart disease,now is taking asprin, immunosuppressive agent,Antiepileptic drugs
  4. pregnancy or plan to pregnant in one year
  5. can't understand the requirement of this study
  6. disfunction of thyroid

Sites / Locations

  • Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

vitamin D intervention group(NGR)

control group(NGR)

vitamin D intervention group(IGR)

control group(IGR)

Arm Description

normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.

normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. only receive lifestyle intervention.

impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.

impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. only receive lifestyle intervention.

Outcomes

Primary Outcome Measures

Change in glucose metabolism
change in Insulin sensitivity index,insulin resistance,inflammatory factors

Secondary Outcome Measures

change in Lipid metabolism
change in triglyceride,cholesterol,HDL,LDL and FFA(free fatty acid)
change in metabolism of calcium and phosphorus
change in calcium, phosphorus,the ratio of urine calcium and creatinine

Full Information

First Posted
May 1, 2017
Last Updated
May 5, 2017
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03138616
Brief Title
The Impact of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Former Gestational Diabetes Mellitus
Official Title
The Impacts of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Vitamin D Deficiency and Former Gestational Diabetes Mellitus:A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is reported that the level of vitamin D is lower during pregnancy and postpartum in the women with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D supplementation to women after birth with previous gestational diabetes may improve glucose metabolism.
Detailed Description
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. GDM can not only have an adverse effect on the pregnant women and the developing fetus, but also can have long lasting effects after birth. GDM can elevates risks of abnormal glucose metabolism postpartum. Vitamin D deficiency has been shown to be associated with insulin resistance and impaired β-cell function. Our previous research also implied that the level of vitamin D is much lower in the women of impaired glucose regulation after birth with history of GDM. This prospective randomized, control clinical trial was designed to evaluate the effects of vitamin D administration on insulin resistance and β-cell function among women with vitamin D deficiency(25OHD <50 ng/mL)and previous GDM. Participants with vitamin D deficiency and previous GDM were divided into normal glucose regulation group(NGR) (n=90) and impaired glucose regulation group(IGR)(n=90) according to the oral glucose tolerance test (OGTT) around 42 days postpartum. And each group was further divided into intervention group and control group, Participants in the intervention group took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention. The control group only receive lifestyle intervention. This study aimed to evaluate the impact of vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of inflammation in Chinese women with former GDM and vitamin D insufficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational diabetes mellitus, vitamin D, postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
intervention group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D intervention group(NGR)
Arm Type
Experimental
Arm Description
normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.
Arm Title
control group(NGR)
Arm Type
No Intervention
Arm Description
normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. only receive lifestyle intervention.
Arm Title
vitamin D intervention group(IGR)
Arm Type
Experimental
Arm Description
impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.
Arm Title
control group(IGR)
Arm Type
No Intervention
Arm Description
impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. only receive lifestyle intervention.
Intervention Type
Drug
Intervention Name(s)
vitamin D
Intervention Description
take 1600 units of vitamin D daily for nine months
Primary Outcome Measure Information:
Title
Change in glucose metabolism
Description
change in Insulin sensitivity index,insulin resistance,inflammatory factors
Time Frame
9 months
Secondary Outcome Measure Information:
Title
change in Lipid metabolism
Description
change in triglyceride,cholesterol,HDL,LDL and FFA(free fatty acid)
Time Frame
9 months
Title
change in metabolism of calcium and phosphorus
Description
change in calcium, phosphorus,the ratio of urine calcium and creatinine
Time Frame
9 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants with vitamin D deficiency and previous GDM
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: with previous GDM,40-50 days after birth - with deficiency of vitamin D(25-(OH)D3<50nmol/L) Exclusion Criteria: type 1 diabetes,type 2 diabetes and other type of diabetes server disfunction of liver and kidney(ALT >100U/L,Cr>132ummol/L) with mental disease,sever anemia,sever infection,sever heart disease,now is taking asprin, immunosuppressive agent,Antiepileptic drugs pregnancy or plan to pregnant in one year can't understand the requirement of this study disfunction of thyroid
Facility Information:
Facility Name
Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22019791
Citation
Nsiah-Kumi PA, Erickson JM, Beals JL, Ogle EA, Whiting M, Brushbreaker C, Borgeson CD, Qiu F, Yu F, Larsen JL. Vitamin D insufficiency is associated with diabetes risk in Native American children. Clin Pediatr (Phila). 2012 Feb;51(2):146-53. doi: 10.1177/0009922811417290. Epub 2011 Oct 20.
Results Reference
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PubMed Identifier
19781131
Citation
von Hurst PR, Stonehouse W, Coad J. Vitamin D supplementation reduces insulin resistance in South Asian women living in New Zealand who are insulin resistant and vitamin D deficient - a randomised, placebo-controlled trial. Br J Nutr. 2010 Feb;103(4):549-55. doi: 10.1017/S0007114509992017. Epub 2009 Sep 28.
Results Reference
background
PubMed Identifier
21715514
Citation
Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial. Am J Clin Nutr. 2011 Aug;94(2):486-94. doi: 10.3945/ajcn.111.011684. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
26000285
Citation
Pleskacova A, Bartakova V, Pacal L, Kuricova K, Belobradkova J, Tomandl J, Kankova K. Vitamin D Status in Women with Gestational Diabetes Mellitus during Pregnancy and Postpartum. Biomed Res Int. 2015;2015:260624. doi: 10.1155/2015/260624. Epub 2015 Apr 27.
Results Reference
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The Impact of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Former Gestational Diabetes Mellitus

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