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Insulin Resistance clinical trials

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NCT ID: NCT02525276 Not yet recruiting - Metabolic Syndrome Clinical Trials

Female Sex Hormones, Insulin Resistance and Effects of Exercise in a Human Experimental Model of Menopause

Start date: August 2015
Phase: N/A
Study type: Interventional

The main objective of this study is to investigate the role of female sex hormones in relation to insulin resistance in a controlled human experimental model of menopause and to explore whether exercise and/or hormone treatment (HT) can compensate for loss of endogenous sex hormone production by maintaining insulin sensitivity and metabolic activity at a level equivalent to what is seen in premenopausal women. Loss of ovarian function is associated with an increased incidence of metabolic disease including metabolic syndrome, type 2 diabetes and cardiovascular disease. This increased disease incidence seems to be related to changes in body composition including decreased skeletal muscle mass and increased visceral fat mass as well as decreased whole body fat oxidation and energy expenditure. Regular physical activity decreases general mortality among other things by increasing fat free mass and insulin sensitivity and hereby prevents metabolic syndrome and cardiovascular disease - conditions seen with an increased incidence after menopause and could therefore be a possible treatment. In the present study the Investigators will assess the role of sex hormones in a model of menopause where healthy women are undergoing planned bilateral oophorectomy due to risk of hereditary ovary cancer. The use of this model makes it possible to control the time point for loss of ovarian function and hereby investigate the timeframe and possible contributing factors in a strictly controlled model. 48 premenopausal women will be included in the study. The study is conducted in women who have already been offered surgical oophorectomy. The first 2 months the study will be an observational cohort study. Hereafter the patients will be allocated to one of four groups (n=12) in a randomized controlled trial, addressing the effects of 6 months of exercise with or without HT. Type of surgery has been decided before inclusion based on medical indications. The women will be offered HT according to national guidelines, but the choice is up to them. Randomization applies only to the training intervention. Firstly the Investigators aim at investigating the role of endogenous female sex hormones and HT in relation to insulin resistance, whole body fat oxidation and -energy expenditure, changes in visceral fat mass and fat free mass after oophorectomy. Secondly, the Investigators wish to study the molecular mechanisms behind the oophorectomy-induced insulin resistance with a focus on insulin signaling in skeletal muscle and fat tissue. Lastly, the investigators aim to explore whether exercise and/or HT can compensate for loss of endogenous female sex hormone production by maintaining IS and metabolic activity, hereby preventing future incidents of metabolic disease in relation to menopause. All in all, this project will contribute with new knowledge concerning the question of how endogenous female sex hormones affect insulin sensitivity and metabolic functioning and how exercise may be used as a disease preventive modality for middle-aged women.

NCT ID: NCT02337894 Not yet recruiting - Insulin Resistance Clinical Trials

Effects of Amino Acid Supplementation on Liver Lipid Content and Protein Metabolism in Obese Children

Start date: January 30, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of an eight-week dietary supplementation with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body composition in obese pre-pubertal children.

NCT ID: NCT02220036 Not yet recruiting - Diabetes Clinical Trials

Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

Start date: June 2014
Phase: N/A
Study type: Interventional

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.

NCT ID: NCT02178839 Not yet recruiting - Clinical trials for Non Alcoholic Fatty Liver Disease

The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease

Start date: July 2014
Phase: N/A
Study type: Interventional

The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.

NCT ID: NCT02133755 Not yet recruiting - Insulin Resistance Clinical Trials

Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study

PCOS-Pilot
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to determine the effect of dopamine agonist therapy on insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is more significant in obese women with PCOS, even lean women can be insulin resistant. No current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may have a pathogenetic role in the development of PCOS. No study to date has assessed the impact of dopamine agonist therapy on IR in patients with PCOS.

NCT ID: NCT02088424 Not yet recruiting - Recurrent Abortion Clinical Trials

the Insulin Resistance in Recurrent Miscarriage IN RECURRENT ABORTION

Start date: March 2014
Phase: N/A
Study type: Observational [Patient Registry]

THE INSULIN RESISTANCE IN RECURRENT ABORTION

NCT ID: NCT01776476 Not yet recruiting - Critical Illness Clinical Trials

A Randomized Controlled Trial of Glutamine Dipeptide in Severe Trauma

GLND Trauma
Start date: February 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if giving certain amino acids to critically injured patients can improve their condition or recovery, and lower their blood sugar and insulin needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine. Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA) for intravenous use. However, it is approved by many countries in Europe, Asia and South America. Several studies suggest that giving glutamine has certain benefits in patients who need intensive care. In a study done at Emory University Medical Center using the same dose of glutamine, the number of hospital infections was lower in patients who had had cardiac, blood vessel or intestinal surgery compared to similar patients who received standard feedings without glutamine. No side effects were thought to be due to giving glutamine in that small study. This study is only being done at Vanderbilt University. The investigators plan to enroll 24 patients in the Trauma ICU over the next 12 months.

NCT ID: NCT01502826 Not yet recruiting - Inflammation Clinical Trials

Mechanisms of Atherogenesis During Post-prandial Time in Childhood Obesity

Start date: February 2012
Phase: N/A
Study type: Observational

Childhood obesity is increasing at a fast pace, together with its complications. The aim of the present study is to assess several candidate triggering agents, mechanisms and intermediate phenotypes of atherosclerosis during the post-prandial phase in the obese insulin-resistant child/adolescent.

NCT ID: NCT00264940 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Diagnosis of Insulin Resistance: 13C-Glucose Breath Test Vs HOMA Index.

Start date: n/a
Phase: N/A
Study type: Observational

The prevalence of type 2 diabetes is rising in the population for many years. It is now recognized that a period of glucose intolerance precedes the clinical symptoms appearance. This is due to a combination of b-cell dysfunction and insulin resistance. It is estimated that this pre-clinical phase of type 2diabetes may antedate the onset of overt diabetes by 10-12 years. Furthermore, insulin resistance is considered to be a main component of the metabolic syndrome and associated with significant cardiovascular morbidity and mortality. Recently, there has been an effort to pinpoint the pre-diabetic phase for early therapeutic intervention in the individual. These studies, in patients with impaired glucose intolerance, have shown to be beneficial from both lifestyle change and pharmacological intervention. It is thus hypnotized that intervention in patients with insulin resistance with or without glucose intolerance may prevent the progress of type 2 diabetes and it’s complications. There is difficulty in identifying individuals who are at high risk for type 2 diabetes. The prevention strategy relies on intervention in a pre-diseased state. In the case of type 2 diabetes, the early intervention is useful in the phase where there is insulin resistance, but prior to the appearance of glucose intolerance. The diagnosis of insulin resistance is a challenging one. The gold standard in diagnosing insulin resistance is the hyperinsulinemic-euglycemic clamp, but this method is not suitable for routine clinical use. Thus, less invasive methods for evaluation, like homeostasis model assessment (HOMA) and quantitative insulin sensitivity check index (QUICKI), were developed. There is a correlation between HOMA and QUICKI results and the hyperinsulinemic-euglycemic clamp. Both HOMA and QUICKI allow insulin resistance diagnosis. The results from those tests correlate with hyperinsulinemic-euglycemic clamp and allow diagnosing insulin resistance, however, those indexes require serum glucose, insulin measurements and quite complicated calculations. A new method was suggested, non-invasive, sensitive and simple, for the identification of insulin resistance. In normal individuals, in the presence of insulin, glucose is taken up by a variety of cells, undergoes glycolysis and enters the tricarboxylic acid cycle or fat synthesis. In either case, CO2 in produced as a by-product. This CO2 enters the circulation and is discarded by the lungs. The new method is based on the assumption that 13C-glucose is ingested as described and its by-product 13CO2 can be measured in the expired air. In type 2 diabetes and other states of insulin resistance glucose, uptake is impaired and results in blunted 13CO2 production. This hypothesis was tested by Lewanczuc et al. The writers compared the [13C]-glucose breath test with hyperinsulinemic-euglycemic clamp, HOMA and QUICKI indexes. They tested 26 patients at different stages of insulin sensitivity and reported a good correlation of the glucose breath test and the other indexes. We suggest testing a larger group of patients at high-risk to develop type 2 diabetes and compare the glucose breath test with HOMA index.