Obesity Clinical Trial
Official title:
A 6 Week, Blinded, Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
A majority of patients who suffer from mental illness are treated with serotonin regulating
FDA approved medications. Some of these medications also block histamine transmission,
increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote
sedation. All of which lead to weight gain and obesity. Many of these drugs are generally
safe and effective but do carry the risk of a long term side effect in that acute and
gradual weight gain of 10-30 pounds over a few months to a year of treatment. The
detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood
stabilizers and some antidepressants. This weight gain may subsequently add to medical
co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem,
hyperlipidemia… ) This therapeutic manipulation of brain serotonin functioning may be
associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It
is possible that insulin resistance occurs as a direct effect or as an indirect effect of
weight gain, particularly in patients prone to weight gain or diabetes due to genetic
loading. Leptin, a chemical associated with feedback signaling that reduces appetite and
adipose tissue growth may also become insensitive. These multiple insults may lead to the
worst weight gain in patients taking clozapine, olanzapine, and mirtazapine.
Diet and exercise and lifestyle modification are the usual initial interventions, though
being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to
make these changes. In fact most of the studies which look at these weight loss
interventions occur in patients who are institutionalized, on restricted diets and may
respond to token economy systems while on longer term inpatient unit stays. This token
economy approach is not easily translated to usual outpatient or short term inpatient
practice settings. In these settings, if lifestyle modification approaches fail, patients
may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry
significant side effect risks. Some patients are even placed on the epilepsy medications
such as zonisamide or topiramate at an even greater side effect risk.
In a similar weight gain prone group, there is growing literature in the diabetes population
that the use of high dose chromium improves (lowers) insulin resistance by way of increasing
insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower
fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in
blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium
piccolinate was studied in depressed patients, especially those with atypical features
(usually fatigue, weight gain, carbohydrate cravings). Although there was no change in
depression symptoms overall, carbohydrate cravings improved. This paper was presented at the
2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in
non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering
blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute ,
clinically significant weightgain in serotonergically treated psychiatric inpatients. The
authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus
protect against weight gain side effects.
Given this pivotal paper in the depressed population, effectiveness data in the diabetes
population and some possible metabolic ties between these two populations, the author wishes
to study the effect of chromium piccolinate in mentally ill subjects who are being started
on serotonergic manipulating medications while in an inpatient treatment setting. These
patients will be followed during their inpatient stay and then be followed after discharge
for a single visit to determine acute interventional effects of chromium piccolinate. We
feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications
that we currently use and therefore suggest a long term randomized, controlled study where
subjects will receive active drug (chromium piccolinate) or placebo at the start of any
serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be
obtained from the Nutrition 21 company, which has been approved by the FDA as a source of
this product.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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