NCT03824379

Brief Summary

Higher prevalence of hypomagnesaemia in diabetic patients with nephropathy was compared to those without nephropathy. Serum magnesium levels were significantly inversely correlated with serum creatinine and U-A/C ratio, and positively correlated with glomerular filtration rate (GFR). Hence, Magnesium supplementation using magnesium salts could be a good approach to improve the cardiovascular complications, insulin resistance index, lipid profile and kidney function in diabetic nephropathy patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 26, 2019

Last Update Submit

January 11, 2021

Conditions

Diabetic Nephropathies

Keywords

magnesiumdiabetic nephropathyosteocalcin

Outcome Measures

Primary Outcomes (1)

  • Change of Human Serum Osteocalcin level

    Evaluation of the extent of cardiovadcular events

    Change from baseline Human Serum Osteocalcin level at 12 weeks

Secondary Outcomes (11)

  • Serum Insulin

    Samples will be measured at baseline and after 12 weeks

  • The homeostasis model assessment-estimated insulin resistance (HOMA-IR)

    Assessed at baseline and after 12 weeks

  • Hemoglobin A1c level

    Samples will be measured at baseline and after 12 weeks

  • Fasting and Post Prandial Blood Sugar level

    Samples will be measured at baseline and after 12 weeks

  • Serum creatinine

    Samples will be measured at baseline and after 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Magnesium arm

EXPERIMENTAL

30 patients will receive the standard therapy (anti-diabetic ) + magnesium supplement

Dietary Supplement: Magnesium citrateDrug: Antidiabetic

Control

ACTIVE COMPARATOR

30 patients will receive the standard therapy (anti-diabetic)

Drug: Antidiabetic

Interventions

Magnesium citrateDIETARY_SUPPLEMENT

magnesium citrate equivalent 20-30 mmol elemental magnesium

Magnesium arm
AntidiabeticDRUG

insulin or oral hypoglycemics

ControlMagnesium arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Type I or II diabetic patientCKD stage 3 ( eGFR = 30 - 59 ml/min) or stage 4 ( eGFR 15-29 ml/min)
  • Proteinuria 30-300 mg/dl (microalbuminuria)
  • Low SMg levels (1.4-1.9 mg/dL; 0.58-0.78 mM) to normal (1.7-2.4 mg/dL; 0.7 -1.1 mmol/L; 1.4-2.0 mEq/L).
  • Life expectancy \>12 months.
  • Women of child-bearing age should be using contraceptives as Hormonal contraceptive or Intra-uterine device.

You may not qualify if:

  • Kidney donor recipient.
  • Current treatment with Mg supplements.
  • Any condition impairing intestinal absorption of Mg (e.g: chronic pancreatitis, short bowel syndrome)
  • Active malignancy.
  • Pregnancy or breastfeeding.
  • Cardiac Arrythmias.
  • Allergy towards the Mg supplement.
  • Participation in other interventional trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasseia, 12345, Egypt

Location

Related Publications (1)

  • Halawa N, Elsaid TW, El Wakeel LM, Shawki MA. Impact of magnesium supplementation on clinical outcome and disease progression of patients with diabetic nephropathy: a prospective randomized trial. Ther Adv Chronic Dis. 2023 Dec 12;14:20406223231214641. doi: 10.1177/20406223231214641. eCollection 2023.

    PMID: 38107482DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

magnesium citrateHypoglycemic Agents

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Nihal Halawa

    Faculty of Pharmacy - Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized controlled open label study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical Pharmacist

Study Record Dates

First Submitted

January 26, 2019

First Posted

January 31, 2019

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)