BridgeMD
New treatment option for Diabetes Mellitus, Type 2
Official title Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT06861062
What this study is testing
What is Vitamin D3?
Vitamin D3 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as cholecalciferol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, double-blind, placebo-controlled trial involving 2,500 individuals aged 40-79 with type 2 diabetes (T2D). The trial includes a 2-year intervention period followed by a 3-year post-intervention follow-up.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 79
You may be able to join if
- Type 2 diabetes mellitus diagnosed by a physician based on the diagnostic criteria outlined in the Guideline for the Prevention and Treatment of...
- Men or women aged 40-79 years;
- Convenient access to the study centers and permanent residence in the vicinity for the next five years;
- Voluntary participation and signed written informed consent.
You likely can't join if
- History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary...
- History of severe diabetic microvascular complications (diabetic nephropathy with an estimated glomerular filtration rate (eGFR) \< 30 mL/(min...
- History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis;
- History of kidney stones, hypercalcemia, or hyperparathyroidism;
- History of severe liver disease, severe kidney disease, severe gastrointestinal disease, severe infectious diseases, severe sarcoidosis or other...
- Laboratory evaluation:
See the full eligibility criteria
- Type 2 diabetes mellitus diagnosed by a physician based on the diagnostic criteria outlined in the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 Edition);
- Men or women aged 40-79 years;
- Convenient access to the study centers and permanent residence in the vicinity for the next five years;
- Voluntary participation and signed written informed consent.
- History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary revascularization) within the past 6 months;
- History of severe diabetic microvascular complications (diabetic nephropathy with an estimated glomerular filtration rate (eGFR) \< 30 mL/(min 1.73m²), proliferative diabetic retinopathy, confirmed diabetic peripheral...
- History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis;
- History of kidney stones, hypercalcemia, or hyperparathyroidism;
- History of severe liver disease, severe kidney disease, severe gastrointestinal disease, severe infectious diseases, severe sarcoidosis or other granulomatous diseases, severe mental illness, or any other condition...
- Laboratory evaluation:
- Blood calcium levels greater than or equal to the normal range for the clinical site's laboratory;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels higher than 3 times the normal range for the clinical site's laboratory;
- eGFR \< 30 mL/(min 1.73m²);
- Individuals currently taking vitamin D supplements (\>400 IU/day), calcium supplements (\>600 mg/day), yeast β-glucan supplements (\>250 mg/day), or those with a history of allergy or intolerance to vitamin D or...
- Participation in other clinical trials within the past 3 months;
- Planning to become pregnant within the next five years, or currently pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, China
- Tangshan, Hebei, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanning, Guangxi, China; Tangshan, Hebei, China; Shiyan, Hubei, China; Wuhan, Hubei, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.