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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D intervention group(NGR) | Experimental | 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. |
|
| control group(NGR) | No Intervention | 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 | 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. |
|
| control group(IGR) | No Intervention | impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum. only receive lifestyle intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Drug | take 1600 units of vitamin D daily for nine months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose metabolism | change in Insulin sensitivity index,insulin resistance,inflammatory factors | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in Lipid metabolism | change in triglyceride,cholesterol,HDL,LDL and FFA(free fatty acid) | 9 months |
| change in metabolism of calcium and phosphorus | change in calcium, phosphorus,the ratio of urine calcium and creatinine |
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Inclusion Criteria:
Exclusion Criteria:
Participants with vitamin D deficiency and previous GDM
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital, Shanghai Jiao Tong University 100 Haining Road,Shanghai | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22019791 | Background | 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. | |
| 19781131 | Background |
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intervention group and control group
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| 9 months |
| 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. |
| 21715514 | Background | 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. |
| 26000285 | Background | 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. |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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