Abstract
M.Tech. (Homoeopathy)
Insulin resistance is defined as the impaired ability of plasma insulin to facilitate peripheral glucose disposal, suppress hepatic gluconeogenesis and inhibit very low density lipoprotein (VLDL) output (Caceres et al., 2008). Insulin resistance is not a disease, but rather a feature and attribute of the Metabolic Syndrome, which is associated with a high risk of developing type two diabetes mellitus and cardiovascular disease (Brewer, 2005). Insulin resistance (IR) is globally regarded as the common and fundamental aetiological factor of the various components of the Metabolic Syndrome namely abdominal obesity, dyslipidaemia, insulin resistance and hypertension (Zimmet, 1991; Haffner et al., 1992 Stern, 1997; Beck Nielson & Groop, 1994; Tsai et al., 2012). Diabetes mellitus type 2 is a rapidly growing worldwide epidemic, but only diagnosed once the underlying metabolic abnormalities have caused damage. The fact that many recently diagnosed diabetic patients already suffer from so called “late complications of diabetes” indicates that the pre-diabetic condition is harmful to health and needs to be addressed promptly to slow down or avoid the progression to diabetes mellitus type 2 (Beck Nielson & Groop, 1994; Brewer, 2005; Tsai et al., 2012).
Treatment of insulin resistance proves very difficult as dietary and lifestyle choices play an integral role in the development, treatment and management of insulin resistance; and insulin resistant patients also seem resistant to changing their behaviour (Brewer, 2005). Current conventional treatment options are limited in efficacy and may be associated with significant side-effects (Brewer, 2005; Snyman, 2009; Neal, 2003), while coherent studies on combination complementary forms of treatment are lacking (Chen et al., 2003; Guan et al., 2000; Hull, 2008; Verma et al., 1998; Winston & Kuhn, 2007; Ye et al., 2001).
This study aimed to determine the efficacy of the herbal and nutritional formulation Glucostate™ in FoodState® form, on the HOMA index of insulin resistant patients.
This was a collaborative randomized double-blind and double-dummy placebo controlled quantitative research study that included 40 participants. Due to the inherent nature of associated race, age and gender bias, participants were matched according to these criteria and randomly allocated to either an experimental or control group (Appendix C). The placebo group was shared between two collaborative studies. Participants volunteered to participate in the study, were between the ages of 20-45 years and consented to the procedures of the study. Participants in the treatment group received Glucostate™ tablets and placebo drops and the participants in the placebo group received placebo tablets and placebo drops.
The research study was conducted over a period of 16 weeks per participant at the University of Johannesburg Health Training Centre, Doornfontein Campus. Participants were asked to maintain their original lifestyle and diet and continue as is normal for them, as alterations in weight have an effect on insulin levels. Participants were screened using blood pressure, abdominal girth, height, weight and Body Mass Index (BMI); these measurements were repeated at weeks 4, 8, 12 and 16. Fasting blood tests consisting of a lipogram, fasting glucose and fasting insulin level were done prior to and at the conclusion of the study. The Homeostasis Model Assessment (HOMA) index was calculated from the fasting insulin and glucose values.
Results acquired from the research study were statistically analyzed by Statkon at the University of Johannesburg by means of descriptive statistics, parametric and non-parametric tests. The only parameters which showed statistically significant improvement for the Glucostate™ group and not the placebo group were systolic blood pressure (SBP) (p=0.004) and diastolic blood pressure (DBP) (p=0.050). There was no statistically significant change in any of the other parameters when compared to placebo.
This research study determined that Glucostate™ was not effective in reducing insulin resistance and the parameters directly associated with its measurement especially when compared to the effects of placebo.