Effect of Melatonin Drug on Metabolic Syndrome

This study aimed at assessing the effect of melatonin in its effectiveness in managing metabolic syndrome. The study used randomised placebo control study to assess levels of glucose, insulin, triglyceride and total cholesterol. The results of this study showed that the melatonin drug is effective in reducing insulin and triglycerides among the disease group of participants as compared to control group with stastical significance of 0.05 at 95% CI.

To evaluate the effect of Melatonin drug on metabolic syndrome
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Abstract
Metabolic syndrome is a condition which results from various risk factors which are
associated with elevated insulin, cardiovascular and type II diabetes. The state of metabolic
condition presents a medical condition which calls for effective drug management regime.
The occurrence of the multi factorial factors calls for effective medical management. Drugs
have been developed however; still the risk factors associated with metabolic disease seems
to reoccur. This study aimed at assessing the effect of melatonin in its effectiveness in
managing metabolic syndrome. The study used randomised placebo control study to assess
levels of glucose, insulin, triglyceride and total cholesterol. Using analysis of variances, the
results of this study showed that the melatonin drug is effective in reducing insulin and
triglycerides among the disease group of participants as compared to control group with
stastical significance of 0.05 at 95% CI. Thus this shows that the drug is effective in
decreasing the oppressive effects of metabolic syndrome and its secondary effects of causing
type II diabetes and Cardiovascular diseases liked to triglycerides.

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Introduction
Metabolic syndrome refers to a constellation of various metabolic risk factors which appear
to elevate the risks of cardiovascular disease, type II diabetes and other related cancers,
(Davis & Kaklamani, 2012). The present pharmacological treatments for various metabolic
syndrome diseases do exist, however, this treatment are not always effective and has been
associated with various side effects. With this view, there is a need for finding an alternative
mode of disease arrangement to manage the metabolic syndrome. Several studies have shown
the linkage between the metabolic syndrome and occurrence of blood pressure, type two
diabetes and risks of cardiovascular diseases, (Grundy, 2012 pp 638-642).
The occurrence of these multifactorial factors often reflects the need for complex clinical
management. Its therapeutic treatment engages in healthy lifestyle management, prevention
of risks factors and offering individualized drug management plans. The goal intervention of
this is to decrease the progression of metabolic syndrome occurrence. This will need patient
education and medication adherence and offering patient education on lifestyle management
forms a key basis, (Kaur, 2014). Collaboration on drug management is critical at this phase in
order to manage the state of the disease. A meta-analysis done have shown that there is
effectiveness in drug management and drug-treated interventions. There is a decreased level
of risks factors, thus assessing mechanism of better-improved drug protocol is essential in
order to assess the effect it has on decreasing the risks factors associated with metabolic
syndrome, (Santschi et al., 2014 p 000718)
A melatonin drug with the formula [N-acetyl-5-methoxytryptamine] is an indigenous
compound which has chronobotion anti-inflammatory properties. The critical site of
interaction is pineal gland which releases the circulation response, which releases it into the
circulation which response to the phobic light which is transmitted into the eyes to the
nucleus of suprachiasmatic of the hypothalamus, (Nduhirabandi, du Toit & Lochner, 2012 pp
2015-220 ). The pineal melatonin production is often released from the exposure of light. The
major function of the melatonin is to facilitate and transmit light information to the body, thus
allowing body’s physiological systems to orient into the seasonal and circulation patterns,
( Pevet & Challet, 2011, pp 175-180).
Animal studies and various clinical data has shown that supplemental melatonin can have
metabolic syndrome components which include elevation if the glucose, blood pressure,

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lipids levels, and glucose, (Ríos‐Lugo et al., 2010 pp 343). The evidence obtains suggest that
metabolic syndrome has suppressed levels of melatonin levels and thus likely to have a
beneficial effect on the exogenous supplementation of the melatonin. Evidence obtained from
animal studies and observational studies have shown that they can have protective effects on
the elevated levels of glucose, insulin, high blood pressure, and dyslipidemia. However
currently the evidence suggesting this trend is insufficient and lack of randomized controlled
trials in humans with metabolic syndrome has not been clearly established.
The focus of this experimental study is to offer rational design and the methodological
process of randomized blind, placebo-controlled trial of melatonin drug supplementation
among humans having metabolic syndrome. The study focuses on the recruitment feasibly
assessment of metabolic syndrome with subjects on the duration of drug administration and
to assess if it ameliorates one or several components of glucose, blood pressure, triglycerides
and lipoproteins cholesterol.
Methods and materials
This study randomized the subjects in a double-blind placebo-controlled trial. Ethical
approval for the study was approved from the institutional ethics committees and patients
admitted in a double-blind. Further, the participants who were taking lipid drugs were
excluded from the study.
The participants of the study were subjected to 10 weeks period of high fat dietary. The
eligible participants were able to receive Melatonin drug regiment at the rate of 5 mg for a
period of 4 weeks. Thereafter, the assessment was performed on glucose levels, insulin
levels, cholesterol, and triglycerides.
The study involved subjects over 18 years of age. The metabolic syndrome in this study was
defined by the following parameters; having one r more of the following key conditions;
increased fasting glucose over 100mg/dl, increased blood pressure greater than 130mmHg,
increased triglycerides above 150mg/dl, reduced cholesterol levels of less than 40 mg/dl and
waist circumference assessment in women at greater than 102cm among men and greater than
88 cm among women.
The inclusion and exclusion criterion was to recruit the participants into the study based on
their body profile characteristics. Participants taking other concomitant drugs were eliminated

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from the study. Further subjects who had been subjected to previous diabetes management
were excluded from the study. Further women who were pregnant, breastfeeding and those
planning for preconception, those having the history of any myocardial and cardiovascular-
related diseases, previous GI and narcotic syndrome conditions, taking calcium channel
blockers and taking lipid drugs were excluded from the study.
Lipid and glucose levels were assessed by the participants. The levels of lipid were assessed
using determination of total serum levels and the lipid levels were assessed using
polyethylene high-density method. The results obtained was assessed using SPPS statistical
software version 19, with analysis of variants and two t-tests were used to measure the levels
of significance among the different treatment groups.
Results
General characteristics of the drugs on the key variables under investigation based on their
mean values displayed the following results.
i) Glucose levels
Normal Control Disease Control Melatonin drug
0
50
100
150
200
250
Glucose (mg/dL)
Figure 1Glucose mean values
ii) Insulin levels

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Normal Control Disease Control Melatonin drug
0
5
10
15
20
25
Insulin (uU/mL)
Figure 2Insulin mean values
iii) Total cholesterol levels
Normal Control Disease Control Melatonin drug
0
20
40
60
80
100
120
140
160
Total Cholesterol (mg/dL)
Figure 3Cholesterol levels mean analysis
iv) Triglycerides levels

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Normal Control Disease Control Melatonin drug
0
20
40
60
80
100
120
140
160
Triglycerides (mg/dL)
Figure 4Triglycerides mean values
ANOVA analysis
Table 1 Insulin ANOVA analysis on Disease Control and Melatonin drug effect
ANOVA
Source of Variation SS df MS F P-value
Between Groups 284.2222222 2 142.111111 25.0784314 0.00121968
Within Groups 34 6 5.66666667
Total 318.2222222 8
Table 2Glucose analysis of variance on disease control and the drug treatment
Source of Variation SS df MS F P-value
Between Groups 26210.88889 2 13105.4444 72.0959658
6.3755E
-05
Within Groups 1090.666667 6 181.777778
Total 27301.55556 8
Table 3Total cholesterol on disease control and drug group
Source of Variation SS df MS F P-value

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Between Groups 11222 2 5611
69.271604
9
7.1525E
-05
Within Groups 486 6 81
Total 11708 8
Table 4 Triglycerides ANOVA analysis between disease control and drug groups
Source of Variation SS df MS F P-value
Between Groups 23938.89 2.00 11969.44 59.88 0.00010
Within Groups 1199.33 6.00 199.89
Total 25138.22 8.00
Discussion
The results above show that glucose levels, insulin, triglycerides, and total cholesterol
displayed reduced levels of drug mean values. The drug effect in both the three groups was
shown to be lower among those induced with drug melatonin placebo. On the analysis of
variance, assessment of disease control and melatonin drug therapy indicated a level of
significance with the efficacy of the drug between the groups being statistically significant as
shown in table 1. The mean populations of the subjects are not equal, thus the difference is
practically significant. Glucose analysis showed no statistical significance with the levels of
glucose being equal in both groups. In assessing analysis variation between disease control
and drug management shows no statistical significance as shown in table 2. Triglycerides
assessment showed that there was statistical significance between disease control and drug
groups as, analysis of variance between the two groups indicate statistical significance with a
p-value is 0.0001 at 95%CI as observed in table 4.
Melatonin group showed a significant reduction in insulin and triglycerides levels. Previous
studies have shown conflicting reports on the effects of melatonin on triglycerides, these
studies have shown elevated triglycerides, (Tamura et al., 2008) while others have reported
poor triglycerides levels, (Wakatsuki, Okatani, Ikenoue, Kaneda & Fukaya, 2001 pp 172).
These experiments showed significant reduction effects of the drug on the levels of

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triglycerides compared to control groups. Further melatonin pathway has shown the effect on
the insulin pathway. Glucose tolerance was impaired with supplementation of melatonin
drug, similar to other studies, (McMullan, Curhan, Schernhammer & Forman, 2013).
The limitations of the study were that gender difference was not assessed on the effectiveness
of the drug. Hence gender could be another variable on the effect of melatonin drug on
managing metabolic syndrome risk factors.
Conclusion
The study has revealed that the new drug regime of melatonin has positive effects on the
management of the metabolic syndrome. The drug was effective and statistically significant
in reducing and lowering levels of insulin and triglycerides levels among the participants as
compared to the control group. Thus this new drug is effective in reducing and managing
metabolic syndrome condition among patients suffering from the disease.

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References
Davis, A.A. and Kaklamani, V.G., 2012. Metabolic syndrome and triple-negative breast
cancer: a new paradigm. International journal of breast cancer, 2012.
Grundy, S.M., 2012. Pre-diabetes, metabolic syndrome, and cardiovascular risk. Journal
of the American College of Cardiology, 59(7), pp.635-643.
Kaur, J., 2014. A comprehensive review on metabolic syndrome. Cardiology research
and practice, 2014.
McMullan, C.J., Curhan, G.C., Schernhammer, E.S. and Forman, J.P., 2013. Association
of nocturnal melatonin secretion with insulin resistance in nondiabetic young women.
American journal of epidemiology, 178(2), pp.231-238.
Nduhirabandi, F., du Toit, E.F. and Lochner, A., 2012. Melatonin and the metabolic
syndrome: a tool for effective therapy in obesity‐associated abnormalities?. Acta
physiologica, 205(2), pp.209-223.
Pevet, P. and Challet, E., 2011. Melatonin: both master clock output and internal time-
giver in the circadian clocks network. Journal of Physiology-Paris, 105(4-6), pp.170-182.
Ríos‐Lugo, M.J., Cano, P., Jiménez‐Ortega, V., Fernández‐Mateos, M.P., Scacchi, P.A.,
Cardinali, D.P. and Esquifino, A.I., 2010. Melatonin effect on plasma adiponectin, leptin,
insulin, glucose, triglycerides and cholesterol in normal and high fat–fed rats. Journal of
pineal research, 49(4), pp.342-348.
Santschi, V., Chiolero, A., Colosimo, A.L., Platt, R.W., Taffé, P., Burnier, M., Burnand,
B. and Paradis, G., 2014. Improving blood pressure control through pharmacist
interventions: a meta‐analysis of randomized controlled trials. Journal of the American
Heart Association, 3(2), p.e000718.
Tamura, H., Nakamura, Y., Narimatsu, A., Yamagata, Y., Takasaki, A., Reiter, R.J. and
Sugino, N., 2008. Melatonin treatment in peri‐and postmenopausal women elevates serum
high‐density lipoprotein cholesterol levels without influencing total cholesterol levels.
Journal of pineal research, 45(1), pp.101-105.

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Wakatsuki, A., Okatani, Y., Ikenoue, N., Kaneda, C., & Fukaya, T. 2001. Effects of
short-term melatonin administration on lipoprotein metabolism in normolipidemic
postmenopausal women. Maturitas, 38(2), 171-177.