Type 2 DiabetesNCT01488916
Vitamin D Inadequacy on Postprandial Glucose in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Chii-Min Hwu, MD, 8862287516, chhwu@vghtpe.gov.tw
Chii-Min Hwu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- Vitamin D, Postprandial Glucose, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
incremental areas under the curves of plasma glucose after meal challenge
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
Measured: 20 days
Secondary outcomes (2)
insulin sensitivity and β-cell function indexes from the meal test
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
Measured: 20 days
Meal-related glycemic excursion indexes (∆G, ∆T, BR)from the meal test
Within 20 days of the screening visit, the eligible participants will receive a 3-h mixed meal test for postprandial glucose excursion.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chii-Min Hwu, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488916
- Sponsor's protocol ID
- V100C-144-Protocol-1
- Status last verified
- Dec 2011
- First submitted
- 6 Dec 2011
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Vitamin D Inadequacy on Postprandial Glucose Excursion in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01488916
- Acronym / sponsor ID
- V100C-144-Protocol-1
- Conditions
- Type 2 Diabetes
- Keywords
- Vitamin D, Postprandial Glucose, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
insulin sensitivity and β-cell function indexes from the meal test
Time frame: 20 days
Meal-related glycemic excursion indexes (∆G, ∆T, BR)from the meal test
Time frame: 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chii-Min Hwu, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chii-Min Hwu, MD (886228757516, chhwu@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental areas under the curves of plasma glucose after meal challenge (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.