- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488916
Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus
December 12, 2011 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan
Impacts of Vitamin D Inadequacy on Postprandial Glucose Excursion in Patients With Type 2 Diabetes
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chii-Min Hwu, MD
- Phone Number: 886228757516
- Email: chhwu@vghtpe.gov.tw
Study Locations
-
-
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Taipei, Taiwan, 112
- Recruiting
- Taipei Veterans General Hospital
-
Principal Investigator:
- Chii-Min Hwu, MD
-
Contact:
- Chii-Min Hwu, MD
- Phone Number: 8862287516
- Email: chhwu@vghtpe.gov.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incremental areas under the curves of plasma glucose after meal challenge
Time Frame: 20 days
|
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
|
20 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insulin sensitivity and β-cell function indexes from the meal test
Time Frame: 20 days
|
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
|
20 days
|
Meal-related glycemic excursion indexes (∆G, ∆T, BR)from the meal test
Time Frame: 20 days
|
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
|
20 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
December 6, 2011
First Submitted That Met QC Criteria
December 7, 2011
First Posted (Estimate)
December 8, 2011
Study Record Updates
Last Update Posted (Estimate)
December 14, 2011
Last Update Submitted That Met QC Criteria
December 12, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V100C-144-Protocol-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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