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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36129007

Enrollment

100

Registered

2023-07-10

Start date

2023-08-01

Completion date

Unknown

Last updated

2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM) Nutritional, Metabolic, Endocrine

Interventions

All participants attend four scheduled study visits. At the first visit, participants undergo a physical examination, have blood, urine and stool samples taken, 24 hours ambulatory blood pressure moni

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Glycemic variability measured using a continuous glucose monitoring system (CGMS) from baseline to three months	—

Secondary

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

Measure

Time frame

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

—

Countries

Brazil

Contacts

Public ContactPriscila Boaventura Barbosa de Figueiredo

pribfigueiredo@gmail.com+55 91 32016760

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026