Effect of 1-year oral cholecalciferol on a metabolic profile and blood pressure in poor-controlled type 2 diabetes mellitus: an open-label randomized controlled pilot study

J Endocrinol Invest. 2021 Apr;44(4):791-802. doi: 10.1007/s40618-020-01373-8. Epub 2020 Aug 17.

Abstract

Purpose: Hypovitaminosis D has been associated with many cardio-metabolic disorders, although their pathogenetic link still remains unclear. Our aim was to evaluate whether 1-year vitamin D (D) supplementation could improve glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition.

Methods: In an open-label randomized-controlled pilot study, thirty poor-controlled (HbA1c > 59 mmol/mol) type 2 diabetic patients (age 71.5 ± 3.2 years, M/F 21/9, BMI 29.8 ± 3.6 kg/m2) with hypovitaminosis D (25OHD 22.0 ± 11.3 nmol/l) were randomized to cholecalciferol supplementation (500 UI/kg p.o. weekly, + D) or observation (- D) for one year. Changes in parameters of glucose, lipid and blood pressure control at 3, 6, 9 and 12 months vs. baseline were assessed.

Results: One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively. In the former, a reduction in HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR) was observed after 1 year (p < 0.05 for all comparisons vs. baseline). We noticed a relationship between 1-year mean percentage changes of serum 25OHD and SBP levels (R = - 0.36, p < 0.05).

Conclusion: One-year cholecalciferol supplementation, able to restore D status, significantly improves FG, HbA1c, SBP and HDL-cholesterol levels in patients with poor-controlled type 2 diabetes mellitus and D deficiency.

Keywords: Body composition; Cholecalciferol; Dyslypidemia; Hypertension; Type 2 diabetes mellitus; Vitamin D deficiency.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Pressure / drug effects*
  • Body Mass Index
  • Calcium-Regulating Hormones and Agents / administration & dosage
  • Calcium-Regulating Hormones and Agents / pharmacokinetics
  • Cholecalciferol* / administration & dosage
  • Cholecalciferol* / pharmacokinetics
  • Cholesterol, HDL / blood
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / drug therapy
  • Diabetes Mellitus, Type 2* / physiopathology
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Lipid Metabolism / drug effects*
  • Male
  • Pilot Projects
  • Treatment Outcome
  • Vitamin D Deficiency* / diagnosis
  • Vitamin D Deficiency* / drug therapy
  • Vitamin D Deficiency* / metabolism
  • Vitamin D* / blood
  • Vitamin D* / metabolism

Substances

  • Calcium-Regulating Hormones and Agents
  • Cholesterol, HDL
  • Glycated Hemoglobin A
  • hemoglobin A1c protein, human
  • Vitamin D
  • Cholecalciferol