Clinical trial NCT04636411: Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes
Official title: Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
Keywords: Oral Magnesium
Type 2 Diabetes
Diabetes Control
HbA1c
Inflammation
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Walaa Reda Abdel Fattah Mohamed Badr
name: Marwa Mostafa Ahmed
name: Moushira Hosny Ezzelarab Sayed
name: Nagwa Eid Sobhy Saad
First posted: 2020-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control
timeFrame: 3 months
measure: Inflammation
timeFrame: 3 months
Secondary outcomes:
measure: Serum magnesium level
timeFrame: 3 months
measure: Prevalence of hypomagnesemia
timeFrame: up to 4 weeks
measure: Correlation of serum Mg level
timeFrame: up to 4 weeks
measure: Total or ionized Mg
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mokattam primary health care unit
state: Mokattam
Study officials:
affiliation: Cairo University
name: Nagwa E Saad, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.