Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351566
• Other study ID #: VD3, Prebiotics in Diabetes
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 24, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Huazhong University of Science and Technology
• Contact: Gang Liu, PHD
• Phone: 86-15926238366
• Email: liugang026[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors.

Description:

The goal of this randomized, double-blind, placebo-controlled trial, with a two-by-two factorial design in individuals with type 2 diabetes (T2D) is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease (CVD) risk factors. About 200 subjects with T2D will be included in this study. All participants will provide written informed consent before randomization. Eligible participants must have no history of cancer, macrovascular or microvascular complications at trial entry, and they are required to agree to limited use of vitamin D, prebiotics, probiotics, or synbiotic supplementations, as well as to convenient access to study centers. Safety exclusions include renal failure or dialysis, cirrhosis, history of hypercalcemia, or other conditions that would preclude participation. Eligible participants will be assigned by chance to one of four groups: (1) daily vitamin D3 (1600 IU) and prebiotics (10 grams); (2) daily vitamin D3 (1600 IU) and prebiotics placebo (10 grams); (3) daily vitamin D3 placebo and prebiotics (10 grams); or (4) daily vitamin D3 placebo (1600 IU) and prebiotics placebo (10 grams). Randomization will be computer-generated within sex and age groups. During the run-in period, baseline questionnaires will be designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions, and participants will undergo physical measurements at baseline. Blood, urine, and faeces samples will also be obtained at study centers. Participants in all groups will be required to take two capsules each day, containing either vitamin D3 or vitamin D3 placebo, as well as a strip of prebiotics powder (10 g per strip, brew with warm water) or prebiotics placebo. Participants will receive their capsules and powder at study centers each month. Participants will complete follow-up questionnaires, including information on adherence to trial regimens, outside use of supplementations, development of major illnesses, and potential side effects of the trial agents, at 3 months and 6 months after randomization. Physical measurements and collection of biological samples will be conducted at study centers 6 months after randomization. The primary outcomes, including glycated hemoglobin (HbA1c) and blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), will be measured using blood samples. The data will be collected and analyzed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Type 2 diabetes (meeting any of the following criteria):

Physician-diagnosed type 2 diabetes, use of oral hypoglycemic medication or insulin, fasting blood glucose = 7.0 mmol/L, HbA1c = 6.5% (48 nmol/L), 2-hour plasma glucose (2hPG) = 11.1 mmol/L.

2. Men aged 40-69 years or women aged 40-69 years.

3. Convenient access to study centers.

4. Written informed consent obtained before any trial-related activities.

Exclusion Criteria:

1. History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).

2. History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).

3. History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).

4. History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).

5. Severe liver disease (such as cirrhosis), severe kidney disease (such as renal failure or requiring dialysis), or severe gastrointestinal disease (such as a history of bowel obstruction).

6. Kidney stones, hypercalcemia, parathyroid hormone abnormality.

7. Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis.

8. Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder.

9. Individuals with infectious diseases such as HIV/AIDS, viral hepatitis.

10. Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment.

11. In the past 3 months, those who have taken any vitamin D supplements exceeding 400 IU/day, calcium supplements exceeding 600 mg/day, prebiotics exceeding 2 g/day, or probiotics exceeding 10^8 colony forming units/day.

12. History of allergy or intolerance to vitamin D, prebiotics, or starch.

13. Individuals with unhealthy habits: heavy alcohol consumption (>80 grams/day for males, >40 grams/day for females) or smoking (>40 cigarettes/day).

14. Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues.

15. Those having participated in other clinical trials or studies in the past 3 months.

16. Those who are intent to become pregnant within the next two years, are currently pregnant, or breastfeeding.

17. Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vitamin D3
Vitamin D3 (cholecalciferol), 1600 IU per day.

Dietary Supplement:
• Prebiotics
Prebiotics (inulin), 10g per day.
• Vitamin D3 placebo
Vitamin D3 placebo
• Prebiotics placebo
Prebiotics placebo, 10g per day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)	Concentration of HbA1c, measured in the percentage of hemoglobin	6 months
Primary	Concentration of blood lipids	Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L	6 months
Primary	Metagenomic analysis of the gut microbiota	The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing	6 months
Secondary	Concentration of fasting glucose	Concentration of fasting glucose, measured in mmol/L	6 months
Secondary	Concentration of fasting insulin	Concentration of fasting insulin, measured in milli-International unit/L	6 months
Secondary	Systolic and diastolic blood pressure	The level of systolic blood pressure and diastolic blood pressure, measured in mmHg	6 months
Secondary	Estimated glomerular filtration rate (eGFR)	Calculating the level of eGFR using Chronic Kidney Disease Epidemiology Collaboration equation	6 months
Secondary	Concentration of C-reactive protein (CRP)	Concentration of CRP, measured in mg/dL	6 months
Secondary	Concentration of procalcitonin	Concentration of procalcitonin, measured in pg/mL	6 months
Secondary	Concentration of interleukin-6 (IL-6)	Concentration of IL-6, measured in pg/mL	6 months
Secondary	Concentration of serum 25(OH)D	Concentration of serum 25(OH)D concentrations, measured in nmol/L	6 months
Secondary	Body weight	Weight in kilograms	6 months
Secondary	Waist circumference	Waist circumference in centimeters	6 months
Secondary	Hip circumference	Hip circumference in centimeters	6 months