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临床试验/NCT05774015
NCT05774015已完成不适用

The Effect of Oral Magnesium Supplementation on The Control and Outcomes of Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level: A Double-Blind Randomized Control Trial

Sultan Qaboos University1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2023年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
247
试验地点
1
主要终点
Fasting Blood Glucose (FBG)

研究概览

简要总结

Studies have shown that type 2 diabetic patients (T2DM) may have low serum magnesium levels leading to poor control and outcome of the disease. Supplementation with Mg might improve overall diabetic control and disease outcome. However, there is yet no consensus on whether the ionized (iMg) or the total Mg (tMg) level should be used as a basis to determine the status of Mg in the blood. Recently it was shown that iMg may correlate better with diabetes control than tMg. Therefore, Mg supplements to diabetic patients may improve their disease status. Unfortunately, and to the best of our knowledge all of the available trials on Mg supplementation guided by iMg levels were conducted on healthy volunteers rather than T2DM patients, and they were all for a short period of time (10 days to 10 weeks). Here we hypothesize that supplementations of T2DM patients with Mg based on serum iMg levels correlate better with diabetes control and prognosis. Such hypothesis is supported by a retrospective study that concluded that iMg correlate better with BP control than tMg. In addition, another trial that investigated the effects of three Mg dietary supplements; Mg oxide, Mg citrate and Mg carbonate on healthy female young adults, showed that only Mg oxide led to an increase in the levels of iMg and tMg concentrations when compared to baseline. Furthermore, a case-control study on older diabetic patients revealed a significant association between iMg and HbA1c. This study aims to investigate the effect of supplementing Mg oxide tablets versus placebo tablets guided by serum iMg levels in T2DM patients with or without hypomagnesemia on diabetic control and prognosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The Mg oxide tablets or placebo tablets (a total of 4 bottles, 90 tablets in each coded bottle) will be provided for each participant during the study period. The 4 bottles for each participant will be per-coded to match the randomization labels to ensure a double-blinded process

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 years old).
  • •Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
  • •Had HbA1c ≥ 7% in the last 3 months

排除标准

  • •HbA1c of < 7%.
  • •Fully dependent patients as per clinical frailty score
  • •End stage renal disease (creatinine clearances (CrCl) at < 10ml/min)
  • •With neuromuscular disease
  • •With active solid or hematological malignancies.
  • •With cognitive disorders.
  • •With the following regular medications (baloxavir marboxil, calcium/sodium polystyrene sulfate, raltegravir, or unithiol) due to X category drug-drug interaction (contraindicated combinations) when given concurrently Mg oxide

研究组 & 干预措施

Interventional group (Mg oxide supplementation):

Active Comparator

Interventional group (Mg oxide supplementation): Patients in this group will receive Mg oxide tablet 500 mg (302 mg elemental), with a dosage regimen of 1 table once daily as per the recommended range of the daily dose (from 250 to 500 mg elemental) (29, 31, 41, 45). Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.

干预措施: Magnesium Oxide tablet 500 mg (Dietary Supplement)

Control group (placebo tablets)

Placebo Comparator

Control group (placebo tablets): Patients in this group will receive placebo tablets labeled as 500 mg (302 mg elemental), with a dosage regimen of 1 tablet once daily. Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.

干预措施: Magnesium Oxide tablet 500 mg (Dietary Supplement)

结局指标

主要结局

Fasting Blood Glucose (FBG)

时间窗: 3-month and 12-month

To evaluate the reduction in FBG levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.

Glycated hemoglobin (HbA1c%)

时间窗: 3-month and 12-month

To evaluate the reduction in HbA1c% levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.

次要结局

  • Blood pressure(3-month and 12-month)
  • Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)(3-month and 12-month)
  • Serum creatinine(3-month and 12-month)
  • Total dosage of insulin regimen(3-month and 12-month)
  • lipid profile(3-month and 12-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Mohammed Al za'abi

Professor

Sultan Qaboos University

研究点 (1)

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