Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01488916
First received: December 6, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 diabetes (DM) are less studied. The purposes of the study are to study the effects of vitamin D inadequacy on postprandial glucose excursion and metabolic responses in patients with type 2 DM. This is a cross-sectional study. About 150-180 patients will be screened for serum levels of 25(OH)D. A total of 45 eligible patients will be grouped into three groups by different vitamin D status: vitamin D deficiency, vitamin D insufficiency, and the controls. The patients will receive a mixed meal test for postprandial glucose excursion and metabolic responses. The investigators will use statistical methods to assess the differences in post-challenge glucose and metabolic response among the three groups of patients. The investigators hope the study can explore the relationship between vitamin D and glucose excursion in patients with type 2 DM.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Impacts of Vitamin D Inadequacy on Postprandial Glucose Excursion in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • incremental areas under the curves of plasma glucose after meal challenge [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.


Secondary Outcome Measures:
  • insulin sensitivity and β-cell function indexes from the meal test [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.

  • Meal-related glycemic excursion indexes (∆G, ∆T, BR)from the meal test [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.


Biospecimen Retention:   Samples Without DNA

Serum samples after meal challenge


Estimated Enrollment: 45
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vitamin D deficiency
patients with serum vitamin D levels of the lower tertile
Vitamin D inadequacy
patients with serum vitamin D levels of the middle tertile
Reference group
patients with serum vitamin D levels of the upper tertile

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 diabetes (DM) are less studied. The purposes of the study are to study the effects of vitamin D inadequacy on postprandial glucose excursion and metabolic responses in patients with type 2 DM. This is a cross-sectional study. About 150-180 patients will be screened for serum levels of 25(OH)D. A total of 45 eligible patients will be grouped into three groups by different vitamin D status: vitamin D deficiency, vitamin D insufficiency, and the controls. The patients will receive a mixed meal test for postprandial glucose excursion and metabolic responses. Analysis of variance (ANOVA) will be applied to compare the differences in clinical characteristics among the three groups. Univariate analyses of general linear models will be used to compare the differences in meal-derived metabolic indexes among the three groups, showing effects of confounding variables including age, sex, obesity, and DM-related clinical parameters. Repeated-measures ANOVA will be used to assess the differences in post-challenge glucose and metabolic response in the meal test, with or without adjustments of the above covariates. Pearson and partial correlation procedures will be used to test the correlations of 25(OH)D with clinical parameters including lipid profile, HbA1c, and meal-derived metabolic indexes. Multiple linear regression models will be used in an attempt to compare the degree to which 25(OH)D concentrations is associated with the meal-derived metabolic indexes in these patients. The investigators hope the study can explore the relationship between vitamin D and glucose excursion in patients with type 2 DM.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In the present study, we propose to screen patients with type 2 DM for vatamin D inadequacy. Those with different vitamin D status will be invited to participate in a mixed meal test.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488916

Contacts
Contact: Chii-Min Hwu, MD 886228757516 chhwu@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chii-Min Hwu, MD    8862287516    chhwu@vghtpe.gov.tw   
Principal Investigator: Chii-Min Hwu, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Chii-Min Hwu, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: vghtpe user, Principal Investgator, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01488916     History of Changes
Other Study ID Numbers: V100C-144-Protocol-1
Study First Received: December 6, 2011
Last Updated: December 12, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Vitamin D
Postprandial Glucose
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014