Type 2 DiabetesPhase 3VDLSNCT02132442
Hepatic Dysfunction, Vitamin D Status, and Glycemic Control in Diabetes
A Phase 3 study of Type 2 Diabetes and Nonalcoholic Fatty Liver Disease, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This study is designed to study the effect of vitamin D intake on the severity of fatty liver and poor glucose control in patients with type 2 diabetes and fatty liver disease. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Type 2 Diabetes, Nonalcoholic Fatty Liver Disease, Vitamin D Deficiency
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2016
- Phase
- Phase 3
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children: 10 - 17 years
- Adults: 18 - 50 years
- Type 2 diabetes > 6 mo duration
- 25-hydroxyvitamin D [25(OH)D] level of <20 ng/mL
- Hepatic triglyceride content (HTGC) value of >5.6%
- HbA1c of > 8%;
- Ability to take medication by mouth.
Who cannot join
- Pregnant or lactating women
- Mental deficiency (IQ <70)
- Chronic liver disease
- Disorders of vitamin D metabolism, kidney, or parathyroid disease;
- Calcium and/or vitamin D supplementation
- Mauriac syndrome
- Malabsorption of fat soluble vitamins
- Drug toxicity and alcoholism
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01609
About this study
This study is designed to study the effect of vitamin D intake on the severity of fatty liver and poor glucose control in patients with type 2 diabetes and fatty liver disease.
Read the detailed description
The prevalence of significantly poor glycemic control marked by a hemoglobin A1c (HbA1c) level of ≥ 9.5% in youth with type 2 diabetes (T2D) is 27% 1 and 24.2% in young adults2. Strategies to improve glycemic control in patients with T2D include lifestyle modification, optimization of therapeutic regimens, and correction of comorbid states that impair glycemic control. However, the role of comorbid states on glycemic control in T2D has not been adequately studied. For example, 70% of patients with T2D have nonalcoholic fatty liver disease (NAFLD)3, a potentially serious form of chronic liver disease 4 in which the triad of the development of lipotoxicity-induced mitochondrial dysfunction, activation of inflammatory pathways, and cytokine generation lead to progressive liver damage5. NAFLD is the leading cause of elevated liver enzymes in the US6, and is diagnosed by either liver biopsy or the detection of a hepatic triglyceride content (HTGC) of >5.6% by proton magnetic resonance spectroscopy (1H MRS)2. Despite the high prevalence of NAFLD in T2D, its potential impact on glycemic control through the impairment of hepatic metabolic processes is unclear. This is important because a crucial step in vitamin D metabolism, the hydroxylation of vitamin D at the 25 position, occurs in the liver. The consequence of NAFLD on this critical step in vitamin D metabolism in patients with T2D, and the impact of the resultant 25-hydroxyvitamin D [25(OH)D] deficiency on glycemic control are not well understood. The rationale for this study is that a clear understanding of the role of vitamin D on the pathogenesis of NAFLD is crucial because vitamin D is a prohormone with potent anti-inflammatory properties that inhibit pro-inflammatory cytokines such as tumor necrosis factor- α (TNF-α), interleukin-6, and the activity of macrophages 2 while upregulating the production of anti-inflammatory cytokine, interleukin-10 2which could potentially reverse the effects of insulin resistance (IR) and oxidative stress, the two key components of the 'double hit model' of the pathogenesis of NAFLD. The 'first hit' involves IR-induced hepatocyte lipid accumulation which increases hepatic vulnerability to the components of the 'second hit': oxidative stress and proinflammatory cytokines, leading to mitochondrial dysfunction, inflammation and fibrosis.
The investigators7 previously showed that mild hepatic dysfunction in patients with T2D was associated with a high prevalence (47.5%) of vitamin D deficiency as defined by 25(OH)D level of < 20 ng/mL, as well as poor glycemic control. The investigators further reported a significant inverse relationship between HbA1c and 25(OH)D, and also between 25(OH)D and alanine transaminase. These data suggest that mild hepatic dysfunction could impair vitamin D metabolism and negatively impact glycemic control in patients with T2D. The investigators have also accumulated data 8 to show that 25(OH)D supplementation was associated with a significant reduction in HbA1c in T2D without a significant change in insulin or metformin dose. Histologically, a recent animal study reported significant hepatic steatosis in vitamin D-deficient mice compared to vitamin D-sufficient mice 2.
- Being tested
- Ergocalciferol, placebo
- Keywords
- Children, Adolescents, Adults, Type 2 diabetes, Nonalcoholic fatty liver disease, Vitamin D deficiency
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol, placeboDietary supplement
Also called Vitamin D, Placebo
Ergocalciferol 50000 IU capsules Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | Ergocalciferol 50,000 IU per week for 6 weeks, then bi-weekly for 6 mo Receives: Dietary Supplement: Ergocalciferol, placebo |
| Placebo | Placebo comparator | Placebo capsules, on capsule per week for 6 weeks, then bi-weekly for 6 mo. Receives: Dietary Supplement: Ergocalciferol, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic triglyceride content (HTGC)
Change in hepatic triglyceride content (HTGC) as measured by proton magnetic resonance spectroscopy (1H MRS)
Measured: 6 months
Secondary outcomes (1)
Hemoglobin A1c
Change in glycemic control as measured by HbA1c.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2016
- Study completionOct 2016
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 University of Massachusetts, WorcesterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin U. Nwosu, University of Massachusetts, Worcester
- Investigators
- Benjamin U Nwosu, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132442
- Sponsor's protocol ID
- HSC Docket # H00002866
- Acronym
- VDLS
- Status last verified
- Jan 2017
- First submitted
- 5 May 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Dysfunction, Vitamin D Status, and Glycemic Control in Diabetes
- ClinicalTrials.gov ID
- NCT02132442
- Acronym / sponsor ID
- VDLS / HSC Docket # H00002866
- Keywords
- Children, Adolescents, Adults, Type 2 diabetes, Nonalcoholic fatty liver disease, Vitamin D deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 May 2014 (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.
This study is designed to study the effect of vitamin D intake on the severity of fatty liver and poor glucose control in patients with type 2 diabetes and fatty liver disease.
Detailed description
The prevalence of significantly poor glycemic control marked by a hemoglobin A1c (HbA1c) level of ≥ 9.5% in youth with type 2 diabetes (T2D) is 27% 1 and 24.2% in young adults2. Strategies to improve glycemic control in patients with T2D include lifestyle modification, optimization of therapeutic regimens, and correction of comorbid states that impair glycemic control. However, the role of comorbid states on glycemic control in T2D has not been adequately studied. For example, 70% of patients with T2D have nonalcoholic fatty liver disease (NAFLD)3, a potentially serious form of chronic liver disease 4 in which the triad of the development of lipotoxicity-induced mitochondrial dysfunction, activation of inflammatory pathways, and cytokine generation lead to progressive liver damage5. NAFLD is the leading cause of elevated liver enzymes in the US6, and is diagnosed by either liver biopsy or the detection of a hepatic triglyceride content (HTGC) of >5.6% by proton magnetic resonance spectroscopy (1H MRS)2. Despite the high prevalence of NAFLD in T2D, its potential impact on glycemic control through the impairment of hepatic metabolic processes is unclear. This is important because a crucial step in vitamin D metabolism, the hydroxylation of vitamin D at the 25 position, occurs in the liver. The consequence of NAFLD on this critical step in vitamin D metabolism in patients with T2D, and the impact of the resultant 25-hydroxyvitamin D [25(OH)D] deficiency on glycemic control are not well understood. The rationale for this study is that a clear understanding of the role of vitamin D on the pathogenesis of NAFLD is crucial because vitamin D is a prohormone with potent anti-inflammatory properties that inhibit pro-inflammatory cytokines such as tumor necrosis factor- α (TNF-α), interleukin-6, and the activity of macrophages 2 while upregulating the production of anti-inflammatory cytokine, interleukin-10 2which could potentially reverse the effects of insulin resistance (IR) and oxidative stress, the two key components of the 'double hit model' of the pathogenesis of NAFLD. The 'first hit' involves IR-induced hepatocyte lipid accumulation which increases hepatic vulnerability to the components of the 'second hit': oxidative stress and proinflammatory cytokines, leading to mitochondrial dysfunction, inflammation and fibrosis.
The investigators7 previously showed that mild hepatic dysfunction in patients with T2D was associated with a high prevalence (47.5%) of vitamin D deficiency as defined by 25(OH)D level of < 20 ng/mL, as well as poor glycemic control. The investigators further reported a significant inverse relationship between HbA1c and 25(OH)D, and also between 25(OH)D and alanine transaminase. These data suggest that mild hepatic dysfunction could impair vitamin D metabolism and negatively impact glycemic control in patients with T2D. The investigators have also accumulated data 8 to show that 25(OH)D supplementation was associated with a significant reduction in HbA1c in T2D without a significant change in insulin or metformin dose. Histologically, a recent animal study reported significant hepatic steatosis in vitamin D-deficient mice compared to vitamin D-sufficient mice 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Dietary Supplement: Ergocalciferol, placeboErgocalciferol 50,000 IU per week for 6 weeks, then bi-weekly for 6 mo |
| Placebo | Placebo comparator | Dietary Supplement: Ergocalciferol, placeboPlacebo capsules, on capsule per week for 6 weeks, then bi-weekly for 6 mo. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children: 10 - 17 years
- Adults: 18 - 50 years
- Type 2 diabetes > 6 mo duration
- 25-hydroxyvitamin D [25(OH)D] level of <20 ng/mL
- Hepatic triglyceride content (HTGC) value of >5.6%
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Mental deficiency (IQ <70)
- Chronic liver disease
- Disorders of vitamin D metabolism, kidney, or parathyroid disease;
- Calcium and/or vitamin D supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergocalciferol, placeboAlso: Vitamin D, PlaceboErgocalciferol 50000 IU capsules Microcrystalline cellulose | Dietary supplement | Placebo, Vitamin D supplementation |
Primary outcome
Change in hepatic triglyceride content (HTGC)
Time frame: 6 months
Change in hepatic triglyceride content (HTGC) as measured by proton magnetic resonance spectroscopy (1H MRS)
1 secondary outcome
Hemoglobin A1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
Benjamin U Nwosu, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Type 2 Diabetes and Nonalcoholic Fatty Liver Disease, run by University of Massachusetts, Worcester at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 10 Jan 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic triglyceride content (HTGC) (time frame: 6 months). 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 10 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.