NCT06059833

Brief Summary

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. It may be due to impaired insulin secretion, resistance to peripheral actions of insulin, or both . Chronic hyperglycemia in synergy with the other metabolic aberrations in patients with diabetes mellitus can cause damage to various organ systems, leading to the development of disabling and life-threatening health complications, most prominent of which are microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications leading to a 2-fold to 4-fold increased risk of cardiovascular diseases Mg2+ deficiency is usually identified by the measurement of serum Mg2+ concentration. Hypomagnesemia is defined by a serum Mg2+ concentration \< 0.75 mmol/L, but a deficiency due to low dietary intake in otherwise healthy people is uncommon. Although overt signs of clinical Mg2+ deficiency are not routinely recognized in the healthy population, relatively low Mg2+ intake and/or Mg2+ status have been shown to be associated with chronic diseases, including cardiovascular disease, T2DM, osteoporosis, pulmonary disease, depression, migraine headaches, inflammation, and cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 22, 2023

Last Update Submit

September 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • magnesium perecentage

    evaluate serum Mg level in type 2 DM patients.

    1 year

Study Arms (2)

cases group

Diagnostic Test: Magnesium

control group

Diagnostic Test: Magnesium

Interventions

MagnesiumDIAGNOSTIC_TEST

The aim of the study is to evaluate serum Mg level in type 2 DM patients.

cases groupcontrol group

Eligibility Criteria

Age30 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type 2 Diabetes Mellitus according to WHO criteria.

You may qualify if:

  • Type 2 Diabetes Mellitus according to WHO criteria.

You may not qualify if:

  • Renal failure patients.
  • Type I DM patients.
  • Acute pancreatitis.
  • Hyperthyroidism.
  • Hyperparathyroidism.
  • Malignancies.
  • Patients on loop/thiazide diuretics.
  • Patients on Mg supplement.
  • Patients on Mg containing antacids.
  • Any other conditions causing low Mg levels were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Zheng L, Zhu X, Yang K, Zhu M, Farooqi AA, Kang D, Sun M, Xu Y, Lin X, Feng Y, Liang F, Zhang F, Linhardt RJ. Correction: Zheng, L., et al. PBN11-8, a Cytotoxic Polypeptide Purified from Marine Bacillus, Suppresses Invasion and Migration of Human Hepatocellular Carcinoma Cells by Targeting Focal Adhesion Kinase Pathways. Polymers 2018, 10, 1043. Polymers (Basel). 2021 Jan 5;13(1):166. doi: 10.3390/polym13010166.

    PMID: 33466568BACKGROUND
  • Galicia-Garcia U, Benito-Vicente A, Jebari S, Larrea-Sebal A, Siddiqi H, Uribe KB, Ostolaza H, Martin C. Pathophysiology of Type 2 Diabetes Mellitus. Int J Mol Sci. 2020 Aug 30;21(17):6275. doi: 10.3390/ijms21176275.

    PMID: 32872570BACKGROUND
  • Piuri G, Zocchi M, Della Porta M, Ficara V, Manoni M, Zuccotti GV, Pinotti L, Maier JA, Cazzola R. Magnesium in Obesity, Metabolic Syndrome, and Type 2 Diabetes. Nutrients. 2021 Jan 22;13(2):320. doi: 10.3390/nu13020320.

    PMID: 33499378BACKGROUND
  • Feng J, Wang H, Jing Z, Wang Y, Cheng Y, Wang W, Sun W. Role of Magnesium in Type 2 Diabetes Mellitus. Biol Trace Elem Res. 2020 Jul;196(1):74-85. doi: 10.1007/s12011-019-01922-0. Epub 2019 Nov 11.

    PMID: 31713111BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

hassnaa M kamel, resident

CONTACT

Elham o Hamd, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-clinical pathology department-sohag hospital university

Study Record Dates

First Submitted

September 22, 2023

First Posted

September 29, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations