Vitamin D, chronic complications of type 2 diabetes mellitus and gut microbiota

Not Applicable

• Conditions: Type 2 diabetes mellitus (T2DM); Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN36129007
• Lead Sponsor: Federal University of Para

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-10
• Last Update Posted: 27 February 2024
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus
2. Older than 30 years of age
3. Regular follow-up with an Endocrinologist
4. Treatment with oral antidiabetic medication at a stable dose for at least 3 months prior to visit 1
5. GFR = 60 mL/min/1,73m 2 for átients with UACR = 30 and = 300mg/g
6. Patients with diabetic renal disease using antihypertensive drugs with nephroprotective effect at a stable dose for at least 4 weeks prior to visit 1
7. 25(OH)D levels = 40 ng/ml

Exclusion Criteria

1. Diagnosis of type 2 or other diabetes types
2. 25(OH)D levels = 12 ng/ml
3. Previous and concomitant history of metabolic bone diseases, liver disease
4. Patients that made use of vitamin D or calcium within the last 3 months
5. Hypo or hyperthyroidism unregulated
6. Breastfeeding, pregnant or women who intend to
7. Comorbidities that could interfere with patients' life expectations according to the researcher's opinion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic variability measured using a continuous glucose monitoring system (CGMS) from baseline to three months<br>

Secondary Outcome Measures

Name	Time	Method
1. Vitamin D (25(OH)D) levels measured using an immonoassay on blood samples collected at baseline and three months<br>2. Autonomic cardiovascular neuropathy measured using a physical examination and ECG at baseline and three months<br>3. Blood pressure variability measured using 24-hour ambulatory blood pressure monitoring (oscillometric method) from baseline to three months<br>4. Gut microbiota pattern measured using Next generation sequencing (NGS) of stool samples from baseline to three months<br>5. Urinary albumin/creatinine ratio assessed by immunoturbidimetry from baseline to three months