Study Protocol: Comparison of Magnesium versus Potassium and Their Combined Effect on Insomnia, Sleep Hormones, Insulin Resistance, and Quality of Life among Patients with Diabetes Mellitus

Sidra Khalid, Shahid Bashir, Shahnai Bashart, Riffat Mehboob, Muhammad Mohsin Aftab, Ayesha Riaz, Ahma Alwazzan, Imran Shahid


Insomnia has been associated with changes in metabolism causing irregular insulin secretion, insulin insensitivity, and poor glucose metabolism, increasing the risk of diabetes mellitus. Magnesium and potassium are electrolytes that play a key role in the regulation of sleep hormones and other factors that contribute to insomnia and diabetes collectively. The study contributes to the literature, as the scientific novelty of the article is targeting the insomnia and diabetes together with potassium and magnesium with a considerable sample size. The Objective of the study was the comparison between magnesium and potassium and determining their combined effect on insomnia, insulin resistance, and quality of life among patients with diabetes mellitus. Methods: In the future, a study with single blind randomized controlled trial will occur. The clinical trial registration number is NCT04642313. The study will occur at the Diabetes Center of Akhuwat Health Services, Lahore, within 18 months. Sample size will be of 320 individuals having diabetes mellitus and insomnia from both genders aged between 19 to 65 years. The control group will be given a placebo. The experimental group will receive the intervention in the form of Magnesium (Mg), Potassium (K), and Mg+K tablets. Outcome measures will include dependent and independent variables along with BMI, blood glucose measurements, and measurement of sleep parameters. Quantitative data will be presented as mean and standard deviation. After the data collection, SPSS Version 25.0 will be used for the analysis. For comparison between treatments ANOVA test will be applied while the chi-square test will be used to analyze categorical data. It is expected that the results will provide useful insights into the effectiveness of clinical interventions on the quality of life among patients with diabetes mellitus.


Keywords: insomnia, diabetes, potassium, magnesium, sleep hormones.

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CHAPUT J. P. and DUTIL C. Lack of sleep as a contributor to obesity in adolescents: impacts on eating and activity behaviors. International Journal of Behavioral Nutrition and Physical Activity, 2016, 13: 1-9.

BOS S. C. and MACEDO A. F. Literature review on Insomnia (2010–2016). Biological Rhythm Research, 2019, 50(1): 94-163.

MORIN C. M. and BENCA R. Chronic insomnia. The Lancet, 2012, 379(9821): 1129-1141.

ARAÚJO T., JARRIN D. C., LEANZA Y., VALLIÈRES A., and MORIN C. M. Qualitative studies of insomnia: Current state of knowledge in the field. Sleep Medicine Reviews, 2017, 31: 58-69.

JAVAHERI S. and REDLINE S. Insomnia and risk of cardiovascular disease. Chest, 2017, 152(2): 435-444.

CHO E. H., LEE H., RYU O. H., CHOI M. G., and KIM, S. W. Sleep disturbances and glucoregulation in patients with type 2 diabetes. Journal of Korean Medical Science, 2014, 29(2): 243-247.

ZHANG S., LI H., ZHANG L., LI J., WANG R., and WANG M. Effects of troxerutin on cognitive deficits and glutamate cysteine ligase subunits in the hippocampus of streptozotocin-induced type 1 diabetes mellitus rats. Brain Research, 2017, 1657: 355-360.

CHOLLET D., FRANKEN P., RAFFIN Y., MALAFOSSE A., WIDMER J., and TAFTI M. Blood and brain magnesium in inbred mice and their correlation with sleep quality. American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, 2000, 279(6): R2173-R2178.

TATSUKI F., SUNAGAWA G. A., SHI S., SUSAKI E. A., YUKINAGA H., PERRIN D., SUMIYAMA K., UKAI-TADENUMA M., FUJISHIMA H., OHNO R. I., and TONE D. Involvement of Ca2+-dependent hyperpolarization in sleep duration in mammals. Neuron, 2016, 90(1): 70-85.

ABBASI B., KIMIAGAR M., SADEGHNIIAT K., SHIRAZI M. M., HEDAYATI M., and RASHIDKHANI B. The effect of magnesium supplementation on primary insomnia in elderly: a double blind placebo-controlled clinical trial. Journal of Research in Medical Sciences, 2012, 17(12): 1161-1169.

SCHMID D., STOLZLECHNER M., SORGNER A., BENTELE C., ASSINGER A., CHIBA P., and MOESLINGER T. An abundant, truncated human sulfonylurea receptor 1 splice variant has prodiabetic properties and impairs sulfonylurea action. Cellular and Molecular Life Sciences, 2012, 69: 129-148.

BUXTON O. M., CAIN S. W., O’CONNOR S. P., PORTER J. H., DUFFY J. F., WANG W., CZEISLER C. A., and SHEA S. A. Adverse metabolic consequences in humans of prolonged sleep restriction combined with circadian disruption. Science Translational Medicine, 2012, 4(129): 129ra43.

SHAN Z., MA H., XIE M., YAN P., GUO Y., BAO W., RONG Y., JACKSON C. L., HU F. B., and LIU L. Sleep duration and risk of type 2 diabetes: a meta-analysis of prospective studies. Diabetes Care, 2015, 38(3): 529-537.

ARORA T., CHEN M. Z., COOPER A. R., ANDREWS R. C., and TAHERI S. The impact of sleep debt on excess adiposity and insulin sensitivity in patients with early type 2 diabetes mellitus. Journal of Clinical Sleep Medicine, 2016, 12(5): 673-680.

NIELSEN F. H., JOHNSON L. K., and ZENG H. Magnesium supplementation improves indicators of low magnesium status and inflammatory stress in adults older than 51 years with poor quality sleep. Magnesium Research, 2010, 23(4): 158-168.

DE BAAIJ J. H., HOENDEROP J. G., and BINDELS R. J. Magnesium in man: implications for health and disease. Physiological Reviews, 2015, 95: 1-46.

FENG J., WANG H., JING Z., WANG Y., CHENG Y., WANG W., and SUN W. Role of magnesium in type 2 diabetes mellitus. Biological Trace Element Research, 2020, 196: 74-85.

COLLINS A. J., PITT B., REAVEN N., FUNK S., MCGAUGHEY K., WILSON D., and BUSHINSKY D. A. Association of serum potassium with all-cause mortality in patients with and without heart failure, chronic kidney disease, and/or diabetes. American Journal of Nephrology, 2017, 46(3): 213-221.

NILSSON E., GASPARINI A., ÄRNLÖV J., XU H., HENRIKSSON K. M., CORESH J., GRAMS M. E., and CARRERO J. J. Incidence and determinants of hyperkalemia and hypokalemia in a large healthcare system. International Journal of Cardiology, 2017, 245: 277-284.

BAAREH L. A., ALSAYED A. R., AYASRAH S., and BASHETI I. A. Effects of a Medication Management Review Service on Patients Diagnosed with Type II Diabetes: A Randomized Controlled Trial. Journal of Southwest Jiaotong University, 2022, 57(6): 840-859.

HAKAEW U., LAOHASIRIWONG W., and SAKPHISUTTHIKUL C. Obesity, Depression, Demographics Factors and Type 2 Diabetes Mellitus among Middle-Aged Population in Thailand. Journal of Southwest Jiaotong University, 2021, 56(6): 580-587.


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