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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT01980459 |
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Date of registration:
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22/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
MagInGlu |
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Scientific title:
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Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01980459 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Kuwait
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Contacts
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Name:
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William B Weglicki, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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George Washington University |
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Name:
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Nadia Zghoul, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dasmin Diabetes Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have documented hypomagnesemia (serum levels = 1.8 mg/dL or 0.74mmol/L);
- Be between 20-70 years of age at the time of randomization
- Have hyperglycemia due to NIDDM metabolic syndrome or obesity
- Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-a)
- Have no active infection
Exclusion Criteria:
- Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);
- Have impaired renal function, defined as eGFR < 60 mL/min/1.73m2 or serum creatinine
> 1.3 mg/dL;
- Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart
block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated
with aldosterone antagonists);
- Are currently pregnant;
- Have chronic inflammatory disorders (e.g. psoriasis);
- Have used of Mg supplements and Mg-rich mineral water within 6 months;
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Insulin Dependent Diabetes Mellitus
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Intervention(s)
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Dietary Supplement: magnesium lactate
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Primary Outcome(s)
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The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.
[Time Frame: One year]
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Secondary Outcome(s)
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Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.
[Time Frame: One year]
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Secondary ID(s)
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IRB#071317
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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