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

NCT06351566 | Completed

• 1 other identifier: VD3, Prebiotics in Diabetes
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Vitamin D; Prebiotics; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Blood Glucose; Lipids

Outcome Measures

Primary Outcomes (3)

• Glycated hemoglobin (HbA1c)

  Concentration of HbA1c, measured in the percentage of hemoglobin

  6 months

• 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

• Metagenomic analysis of the gut microbiota

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

  6 months

Secondary Outcomes (11)

• Concentration of fasting glucose

  6 months

• Concentration of fasting insulin

  6 months

• Systolic and diastolic blood pressure

  6 months

• Estimated glomerular filtration rate (eGFR)

  6 months

• Concentration of C-reactive protein (CRP)

  6 months

Study Arms (4)

Vitamin D3 + Prebiotics

ACTIVE COMPARATOR

Drug: Vitamin D3; Dietary Supplement: Prebiotics

Vitamin D3 + Prebiotics placebo

ACTIVE COMPARATOR

Drug: Vitamin D3; Dietary Supplement: Prebiotics placebo

Prebiotics +Vitamin D3 placebo

ACTIVE COMPARATOR

Dietary Supplement: Prebiotics; Dietary Supplement: Vitamin D3 placebo

Vitamin D3 placebo + Prebiotics placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Prebiotics placebo

Interventions

Vitamin D3 DRUG

Vitamin D3 (cholecalciferol), 1600 IU per day.

Also known as: Cholecalciferol

Vitamin D3 + Prebiotics; Vitamin D3 + Prebiotics placebo

Prebiotics DIETARY_SUPPLEMENT

Prebiotics (inulin), 10g per day.

Also known as: Inulin

Prebiotics +Vitamin D3 placebo; Vitamin D3 + Prebiotics

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D3 placebo

Prebiotics +Vitamin D3 placebo; Vitamin D3 placebo + Prebiotics placebo

Prebiotics placebo DIETARY_SUPPLEMENT

Prebiotics placebo, 10g per day.

Vitamin D3 + Prebiotics placebo; Vitamin D3 placebo + Prebiotics placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Men aged 35-70 years or women aged 35-70 years.
• Convenient access to study centers.
• Written informed consent obtained before any trial-related activities.

You may not qualify if:

• History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).
• History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).
• History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).
• History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).
• 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).
• Kidney stones, hypercalcemia, parathyroid hormone abnormality.
• Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis.
• Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder.
• Individuals with infectious diseases such as HIV/AIDS, viral hepatitis.
• Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment.
• 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.
• History of allergy or intolerance to vitamin D, prebiotics, or starch.
• Individuals with unhealthy habits: heavy alcohol consumption (\>80 grams/day for males, \>40 grams/day for females) or smoking (\>40 cigarettes/day).
• Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues.
• Those having participated in other clinical trials or studies in the past 3 months.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (2)

Bao'an Center Hosipital of Shenzhen

Shenzhen, Guangdong, China

Location

School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Cholecalciferol; Prebiotics; Inulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Fructans

Study Officials

• Gang Liu, PHD

  School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• An Pan, PHD

  School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 8, 2024
• Study Start: April 25, 2024
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)