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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention group and control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin D intervention group(NGR)

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.

Group Type EXPERIMENTAL

vitamin D

Intervention Type DRUG

take 1600 units of vitamin D daily for nine months

control group(NGR)

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

only receive lifestyle intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

vitamin D intervention group(IGR)

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.

Group Type EXPERIMENTAL

vitamin D

Intervention Type DRUG

take 1600 units of vitamin D daily for nine months

control group(IGR)

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

only receive lifestyle intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitamin D

take 1600 units of vitamin D daily for nine months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No