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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Gestational Diabetes Mellitus

Treatments: Drug: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03138616

20160901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

vitamin D intervention group(NGR)

Experimental group

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.

Treatment:

Drug: vitamin D

control group(NGR)

No Intervention group

Description:

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

vitamin D intervention group(IGR)

Experimental group

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.

Treatment:

Drug: vitamin D

control group(IGR)

No Intervention group

Description:

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