Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636411
• Other study ID #: MD-164-2020
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 74 Adult Patients with type 2 diabetes mellitus (T2D) will be enrolled and randomized into 2 groups. The intervention group will receive oral magnesium (Mg) supplementation. The study objectives are:

1. To estimate level of Mg (total and ionized) in patient with type 2 DM.

2. To determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.

3. To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP)

Description:

A total of 74 Adult Patients of both genders who had been diagnosed with T2D and are on oral anti-hyperglycemic drug and their HbA1C between 7and 8 %, will be enrolled in the study. Initially the study protocol will be explained & informed written consent will be obtained from all participants. All subjects will be evaluated to ensure that they meet the eligibility criteria through: Full history taking, complete physical examination and investigations. the intervention group will receive oral magnesium (Mg) supplementation for 3 months (250 mg of elemental magnesium daily). The primary outcome is to determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes with HbA1C between 7 and 8%.

• Both genders will be included in this study.

Exclusion Criteria:

• Patients on insulin.

• Patients on diuretics or angiotensin-converting enzyme inhibitors in the last 2 weeks.

• Patients taking Mg containing supplements within 3 months.

• Patients with significant gastrointestinal disorders (eg, chronic diarrhea).

• Patients with impaired renal functions (eGFR< 60 mL/min).

• Heart block or heart failure

• Patients treated with aldosterone antagonists.

• Pregnant patients

• Patients with evidence of infection.

• Patients with chronic inflammatory conditions eg, SLE

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Oral Magnesium Supplementation
250 mg of elemental magnesium daily for three months

Other:
• Standard Care for diabetic patients
Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines

Locations

Country	Name	City	State
Egypt	Mokattam primary health care unit	Cairo	Mokattam

Sponsors (5)

Lead Sponsor	Collaborator
Samar Fares, MD	Marwa Mostafa Ahmed, Moushira Hosny Ezzelarab Sayed, Nagwa Eid Sobhy Saad, Walaa Reda Abdel Fattah Mohamed Badr

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Dhawan S, Natarajan R. Epigenetics and Type 2 Diabetes Risk. Curr Diab Rep. 2019 Jun 27;19(8):47. doi: 10.1007/s11892-019-1168-8. — View Citation

Saeed H, Haj S, Qasim B. Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level. Endocrinol Diabetes Metab. 2018 Nov 2;2(1):e00048. doi: 10.1002/edm2.48. eCollection 2019 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control	3 months
Primary	Inflammation	To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)	3 months
Secondary	Serum magnesium level	To determine the effect of Mg supplementation for diabetic patient on serum Mg level	3 months
Secondary	Prevalence of hypomagnesemia	To estimate prevalence of hypomagnesemia in patients with type 2 DM.	up to 4 weeks
Secondary	Correlation of serum Mg level	To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).	up to 4 weeks
Secondary	Total or ionized Mg	Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg	3 months

External Links

•   Epigenetics and Type 2 Diabetes Risk
•   Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level