Status:
UNKNOWN
Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Brief Summary
Vitamin D deficiency is associated with an unfavorable metabolic profile in several observational studies. However, the influences of vitamin D concentrations on postprandial glucose in type 2 diabete...
Detailed Description
Vitamin D deficiency is associated with an unfavorable metabolic profile in several observational studies. However, the influences of vitamin D concentrations on postprandial glucose in type 2 diabete...
Eligibility Criteria
Inclusion
- Ambulatory type 2 diabetes patients.
- Men or women.
- Aged 20 \~ 75 years old.
- Stable oral anti-diabetes therapy for at least 8 weeks.
- Willing to participate in the study by signing an informed consent.
- Willing to undergo a screening visit including medical history taking and fasting blood sampling.
- Willing to undergo a standardized mixed meal test at a separate visit.
Exclusion
- Patients of type 2 diabetes with the following: History of HHNK; Fasting glucose higher than 250 mg/dL; Treated with insulin, alpha-glucosidase inhibitor, incretin mimetics, DPP-IV inhibitors or rapid-acting insulin secretagogus (the meglitinides) in the past 8 weeks;
- HbA1c \> 8.5 %.
- History or evidence of parathyroid or calcium-related diseases.
- History or evidence of endocrine diseases including hyperthyroidism, hypothyroidism, adrenal disease and pituitary disease.
- History of major renal, liver, heart, blood and neurological disease, judged by the investigation physicians.
- History or evidence of alcoholism or drug abuse.
- History of surgical operation of upper gastrointestinal tract and liver. Women who are pregnant.
- History of malignancy within the last 5 years
- History of mental incapacity or language barriers that may preclude adequate understanding or cooperation in the study.
- Under systemic glucocorticoid therapy in the past 8 weeks
- Under supplementation of vitamin D, of any kind, in the past 4 weeks
- Under hormonal replacement therapy in the past 8 weeks
- Under treatments for osteoporosis including calcitonin and biphosphate in the past 8 weeks.
- History or evidence of difficult venous access
- Subjects with the following laboratory values: hemoglobin \< 9 g/dL, WBC \< 3000/mL, platelet \< 100,000/mL, serum Cr \> 2.0 mg/dL, ALT \> 3x ULN, total bilirubin \> 2x ULN.
- Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01488916
Start Date
August 1 2011
End Date
December 1 2012
Last Update
December 14 2011
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 112