Diabetes MellitusNCT06059833
Serum Magnesium Level in Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Magnesium
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Adult, Older adult
Study population: Type 2 Diabetes Mellitus according to WHO criteria.
Who may be able to join
- • Type 2 Diabetes Mellitus according to WHO criteria.
Who cannot join
- • Renal failure patients.
- Type I DM patients.
- Acute pancreatitis.
- Hyperthyroidism.
- Hyperparathyroidism.
- Malignancies.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Elham o Hamd, professor contact
About this study
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
- Conditions
- Diabetes Mellitus
- Being tested
- Magnesium
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDiagnostic test
The aim of the study is to evaluate serum Mg level in type 2 DM patients.
| Study group | Role | What they receive |
|---|---|---|
| cases group | Not described Receives: Diagnostic Test: Magnesium | |
| control group | Not described Receives: Diagnostic Test: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnesium perecentage
evaluate serum Mg level in type 2 DM patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Mohamed Kamel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059833
- Sponsor's protocol ID
- Soh-Med-23-07-14MS
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33466568Galicia-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.
PubMed 32872570Piuri 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.
PubMed 33499378Feng 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.
PubMed 31713111
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Magnesium Level in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06059833
- Acronym / sponsor ID
- Soh-Med-23-07-14MS
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Diagnostic Test: Magnesium |
| control group | – | Diagnostic Test: Magnesium |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes Mellitus according to WHO criteria.
Key inclusion criteria (1 listed)
- • Type 2 Diabetes Mellitus according to WHO criteria.
Key exclusion criteria (10 listed)
- • Renal failure patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnesiumThe aim of the study is to evaluate serum Mg level in type 2 DM patients. | Diagnostic test | cases group, control group |
Primary outcome
magnesium perecentage
Time frame: 1 year
evaluate serum Mg level in type 2 DM patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 33466568Zheng 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.
- Background: PubMed 32872570Galicia-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.
- Background: PubMed 33499378Piuri 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.
- Background: PubMed 31713111Feng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham o Hamd, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hassnaa M kamel, resident (01009700227, hasnaamohamed@med.sohage.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnesium perecentage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059833, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.