Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Browse trials for

• Diabetes Mellitus, Type 2 9,359
• Cardiovascular Diseases 4,904

Keywords

• Vitamin D
• yeast β-glucan
• Diabetes Mellitus, Type 2
• Cardiovascular Disease
• glycemic control

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Study arms

• Active comparator
  Vitamin D + yeast β-glucan

  Drug: Vitamin D3 · Dietary Supplement: yeast β-glucan

• Active comparator
  Vitamin D + yeast β-glucan placebo

  Drug: Vitamin D3 · Dietary Supplement: yeast β-glucan placebo

• Active comparator
  yeast β-glucan +Vitamin D placebo

  Dietary Supplement: yeast β-glucan · Dietary Supplement: Vitamin D placebo

• Placebo comparator
  Vitamin D placebo + yeast β-glucan placebo

  Dietary Supplement: Vitamin D placebo · Dietary Supplement: yeast β-glucan placebo

Interventions

• DrugVitamin D3

  Vitamin D3(cholecalciferol),1600 IU per day.

  Also known as: cholecalciferol

• Dietary supplementyeast β-glucan

  yeast β-glucan, 600mg per day.

• Dietary supplementVitamin D placebo

  Vitamin D placebo

• Dietary supplementyeast β-glucan placebo

  yeast β-glucan placebo

Primary outcomes

1. Glycemic control

   Change in HbA1c from baseline to the 24-month visit

   Time frame: 24 months

2. Cardiovascular disease risk

   Change in 10-year ASCVD risk score from baseline to the 24-month visit, assessed using China-PAR score, with a score range of 0-100%, where a higher score means a higher ASCVD risk

   Time frame: 24 months

Secondary outcomes

1. Blood 25(OH)D

   Change in blood 25(OH)D concentrations from baseline to the 24-month visit

   Time frame: 24 months

2. Major cardiovascular events

   Time to the first occurrence of any of the following: myocardial infarction, hospitalized or treated heart failure, stroke, revascularization of coronary arteries, or cardiovascular deaths

   Time frame: 60 months

3. Microvascular disease

   Time to the first occurrence of any of the following: nephropathy, retinopathy, or neuropathy

   Time frame: 60 months

4. All-cause mortality

   Deaths from any causes

   Time frame: 60 months

5. Change in fasting plasma glucose

   Change in fasting plasma glucose from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).

   Time frame: 24 months

6. Change in fasting C-peptide

   Change in fasting C-peptide from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).

   Time frame: 24 months

7. Change in insulin

   Change in insulin from baseline to the 24-month visit. The value is reported in microunit per milliliter (μU/mL).

   Time frame: 24 months

8. Change in HOMA-IR

   Change in HOMA-IR from baseline to the 24-month visit. HOMA-IR = \[Fasting Serum Insulin (μU/mL) × Fasting Plasma Glucose (mmol/L)\] / 22.5. Lower values indicate better insulin sensitivity.

   Time frame: 24 months

9. Change in Lipid profile

   Change in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to the 24-month visit. These values are reported in millimole per liter (mmol/L).

   Time frame: 24 months

10. Change in Liver function markers

    Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), a nd gamma-glutamyl transferase (GGT) from baseline to the 24-month visit. These values are reported in units per liter (U/L).

    Time frame: 24 months

11. Change in serum creatinine

    Change in serum creatinine from baseline to the 24-month visit. The value is reported in micromole per liter (μmol/L).

    Time frame: 24 months

12. Change in cystatin C

    Change in cystatin C from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).

    Time frame: 24 months

13. Change in eGFR

    Change in estimated glomerular filtration rate (eGFR) from baseline to the 24-month visit. The CKD-EPI (2009) method to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL/min/1.73 m²).

    Time frame: 24 months

14. Change in blood calcium

    Change in blood calcium from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).

    Time frame: 24 months

15. Change in body weight

    Change in body weight from baseline to the 24-month visit. The value is reported in kilogram (kg).

    Time frame: 24 months

16. Change in BMI

    Change in body mass index (BMI) from baseline to the 24-month visit. BMI = Body Weight (kg) / \[Height (m)\]\^2. The value is reported in kilogram per square meter (kg/m\^2).

    Time frame: 24 months

17. Change in waist circumference

    Change in waist circumference from baseline to the 24-month visit. The value is reported in centimeter (cm).

    Time frame: 24 months

18. Change in waist-to-hip ratio

    Change in waist-to-hip ratio from baseline to the 24-month visit. Waist-to-hip ratio = Waist Circumference (cm) / Hip Circumference (cm). Higher values indicate greater central adiposity.

    Time frame: 24 months

19. Change in blood pressure

    Change in systolic and diastolic blood pressure from baseline to the 24-month visit. The values are reported in millimeters of mercury (mmHg).

    Time frame: 24 months

20. Change in grip strength

    Change in grip strength from baseline to the 24-month visit, assessed using a handgrip dynamometer. The value is reported in kilogram (kg).

    Time frame: 24 months

21. Change in FRAIL scale

    FRAIL scale comprises five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5, with higher scores indicating greater frailty. Based on the total score, patients were categorized as robust (0 points), pre-frail (1-2 points), or frail (3-5 points).

    Time frame: 24 months

22. Change in C-reactive protein

    Change in C-reactive protein (CRP) from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).

    Time frame: 24 months

23. Change in procalcitonin

    Change in procalcitonin from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).

    Time frame: 24 months

24. Change in interleukin-6

    Change in interleukin-6 (IL-6) from baseline to the 24-month visit. The value is reported in picogram per milliliter (pg/mL).

    Time frame: 24 months

25. Bone mineral density

    Change in bone mineral density from baseline to the 24-month visit, including but not limited to Speed of Sound (SOS), T-score, and Z-score. SOS is reported in meters per second （m/s). T-score and Z-score have no dimensional units.

    Time frame: 24 months

26. Change in baPWV

    Change in brachial-Ankle Pulse Wave Velocity (baPWV) from baseline to the 24-month visit. The value is reported in centimeters per second (cm/s).

    Time frame: 24 months

27. Change in ABI

    Change in Ankle-Brachial Index (ABI) from baseline to the 24-month visit. ABI=Systolic blood pressure of the ankle (mmHg) / Higher values of bilateral arm systolic pressure (mmHg).

    Time frame: 24 months

28. Change in LSM

    Change in stiffness measurement (LSM) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in kilopascal (kPa).

    Time frame: 24 months

29. Change in UAP

    Change in Ultrasound Attenuation Parameter (UAP) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in Decibel per Megahertz per Centimeter (dB/MHz/cm).

    Time frame: 24 months

Other outcomes

1. Other events

   Incidence of other cardiovascular diseases (not listed above), cancer, infectious diseases and falls

   Time frame: 60 months

2. Change in Health-related quality of life

   Change in health-related quality of life from baseline to the 24-month visit, assessed using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, with a score range of 0-100, where a higher score means higher health-related quality of life

   Time frame: 24 months

3. Change in Cognitive function (MoCA)

   Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a one-page 30-point test. Scores range from 0 to 30, with a score of 26 or above considered normal. The change in score from baseline to 24 months will be calculated.

   Time frame: 24 months

4. Change in Cognitive function (MMSE)

   Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The MMSE is a 30-point questionnaire. Scores range from 0 to 30, with different cut-off points for normal cognition based on education level: \>17 for illiterate, \>20 for individuals with ≤6 years of education, and \>24 for individuals with \>6 years of education. The change in score from baseline to 24 months will be calculated.

   Time frame: 24 months

5. Change in depressive mood score

   Change in depressive symptom severity from baseline to the 24-month visit, measured by the Patient Health Questionnaire-9 (PHQ-9) score, with a score range of 0-27, where a higher score means more severe depressive symptoms.

   Time frame: 24 months

6. Change in anxiety score

   Change in anxiety symptom severity from baseline to the 24-month visit, measured by the Generalized Anxiety Disorder-7 (GAD-7) score, with a score range of 0-21, where a higher score means more severe anxiety symptoms and clinical cut point for anxiety disorder was 10 points.

   Time frame: 24 months

7. Change in Sleep quality

   Change in sleep quality from baseline to the 24-month visit, assessed using the Pittsburgh Sleep Quality Index (PSQI), with a score range of 0-21, where a higher score means worse sleep quality.

   Time frame: 24 months

8. Change in BF%

   Change in body fat percentage (BF%) from baseline to the 24-month visit.

   Time frame: 24 months

9. Change in fat mass

   Change in fat mass from baseline to the 24-month visit. The value is reported in kilogram (kg).

   Time frame: 24 months

10. Change in fat-free mass

    Change in fat-free mass from baseline to the 24-month visit. The value is reported in kilogram (kg).

    Time frame: 24 months

11. Concentration of blood metabolites

    Blood metabolites, including, but not limited to, fatty acids and lipoprotein particles, quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS), are reported in mmol/L.

    Time frame: 24 months

12. Metagenomic analysis of the gut microbiota

    The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing

    Time frame: 24 months

13. DNA methylation level

    The relative change in DNA methylation level quantified by pyrosequencing, reported as percentage methylation at specific CpG sites

    Time frame: 24 months

Individual participant data

Plan to share: No — The individual participant data (IPD) sharing will need to be approved by the Institutional Review Board (IRB) and the study investigators with individual specific project request.