Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01488916 |
Recruitment Status
: Unknown
Verified December 2011 by vghtpe user, Taipei Veterans General Hospital,Taiwan.
Recruitment status was: Recruiting
First Posted
: December 8, 2011
Last Update Posted
: December 14, 2011
|
Sponsor:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | December 6, 2011 | |||
First Posted Date | December 8, 2011 | |||
Last Update Posted Date | December 14, 2011 | |||
Study Start Date | August 2011 | |||
Estimated Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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.
|
|||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01488916 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
|
|||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus | |||
Official Title | Impacts of Vitamin D Inadequacy on Postprandial Glucose Excursion in Patients With Type 2 Diabetes | |||
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 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. | |||
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 | |||
Study Design | Observational Model: Case Control Time Perspective: Cross-Sectional |
|||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Serum samples after meal challenge |
|||
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. | |||
Condition | Type 2 Diabetes | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
45 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | December 2012 | |||
Estimated Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 20 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01488916 | |||
Other Study ID Numbers | V100C-144-Protocol-1 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | vghtpe user, Taipei Veterans General Hospital,Taiwan | |||
Study Sponsor | Taipei Veterans General Hospital, Taiwan | |||
Collaborators | Not Provided | |||
Investigators |
|
|||
PRS Account | Taipei Veterans General Hospital, Taiwan | |||
Verification Date | December 2011 |