Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Oral Magnesium Supplementation
Standard Care for diabetic patients
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes focused on measuring Oral Magnesium, Type 2 Diabetes, Diabetes Control, HbA1c, 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
Sites / Locations
- Mokattam primary health care unitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
This group group will receive oral magnesium supplementation (250 mg of elemental magnesium daily for three months) plus the standard care for diabetic patients
This group will receive the standard care for diabetic patients
Outcomes
Primary Outcome Measures
Glycemic control
To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control
Inflammation
To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)
Secondary Outcome Measures
Serum magnesium level
To determine the effect of Mg supplementation for diabetic patient on serum Mg level
Prevalence of hypomagnesemia
To estimate prevalence of hypomagnesemia in patients with type 2 DM.
Correlation of serum Mg level
To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).
Total or ionized Mg
Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg
Full Information
NCT ID
NCT04636411
First Posted
November 8, 2020
Last Updated
November 13, 2020
Sponsor
Samar Fares, MD
Collaborators
Walaa Reda Abdel Fattah Mohamed Badr, Marwa Mostafa Ahmed, Moushira Hosny Ezzelarab Sayed, Nagwa Eid Sobhy Saad
1. Study Identification
Unique Protocol Identification Number
NCT04636411
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samar Fares, MD
Collaborators
Walaa Reda Abdel Fattah Mohamed Badr, Marwa Mostafa Ahmed, Moushira Hosny Ezzelarab Sayed, Nagwa Eid Sobhy Saad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
To estimate level of Mg (total and ionized) in patient with type 2 DM.
To determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
Oral Magnesium, Type 2 Diabetes, Diabetes Control, HbA1c, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This group group will receive oral magnesium supplementation (250 mg of elemental magnesium daily for three months) plus the standard care for diabetic patients
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will receive the standard care for diabetic patients
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Magnesium Supplementation
Intervention Description
250 mg of elemental magnesium daily for three months
Intervention Type
Other
Intervention Name(s)
Standard Care for diabetic patients
Intervention Description
Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines
Primary Outcome Measure Information:
Title
Glycemic control
Description
To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control
Time Frame
3 months
Title
Inflammation
Description
To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Serum magnesium level
Description
To determine the effect of Mg supplementation for diabetic patient on serum Mg level
Time Frame
3 months
Title
Prevalence of hypomagnesemia
Description
To estimate prevalence of hypomagnesemia in patients with type 2 DM.
Time Frame
up to 4 weeks
Title
Correlation of serum Mg level
Description
To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).
Time Frame
up to 4 weeks
Title
Total or ionized Mg
Description
Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar H Fares, Lecturer
Phone
01009403943
Ext
002
Email
Samar.fares@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa R Badr, Specialist
Phone
01111787218
Ext
002
Email
walaareda84@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa E Saad, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mokattam primary health care unit
City
Cairo
State/Province
Mokattam
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa R Badr, Specialist
Phone
01111787218
Ext
002
Email
walaareda84@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study data will be available upon reasonable request from central contact person
IPD Sharing Time Frame
After finalizing the study
IPD Sharing Access Criteria
The study data will be available upon reasonable request from central contact person
Citations:
PubMed Identifier
30815575
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.
Results Reference
background
PubMed Identifier
31250127
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.
Results Reference
background
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/30815575/
Description
Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level
URL
http://pubmed.ncbi.nlm.nih.gov/31250127/
Description
Epigenetics and Type 2 Diabetes Risk
Learn more about this trial
Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs