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Insulin Resistance clinical trials

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NCT ID: NCT01514942 Completed - PCOS Clinical Trials

Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters

Start date: n/a
Phase: Phase 4
Study type: Interventional

Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach. Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug. In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported. In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.

NCT ID: NCT01511822 Completed - Clinical trials for Polycystic Ovary Syndrome

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance

Start date: n/a
Phase: Phase 4
Study type: Interventional

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms. The primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia. Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain. More recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers. It has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation. Due to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance.

NCT ID: NCT01509482 Completed - Insulin Resistance Clinical Trials

Insulin Resistance in Idiopathic Oligospermia and Azoospermia

Start date: January 2012
Phase: N/A
Study type: Interventional

Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.

NCT ID: NCT01505803 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study

Start date: July 2010
Phase: Phase 1
Study type: Interventional

Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of diabetes-associated deaths being attributed to cardiovascular complications. The characterising features of DM include: the presence of chronic hyperglycaemia, consequent upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been shown to influence each of these outcomes via several mechanisms. This pilot study will examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes in a population with type 2 DM.

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: NCT01497106 Completed - Insulin Resistance Clinical Trials

Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

Start date: December 2011
Phase: N/A
Study type: Interventional

This study is being done to understand the effects of calorie restriction and weight loss on muscle protein metabolism in adult men and women.

NCT ID: NCT01496092 Completed - Insulin Resistance Clinical Trials

Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). The investigators will achieve this goal through a randomized controlled trial of administration of usual protein diet plus KA versus usual protein diet alone in patients on peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study will provide potential avenues for improvement of metabolic profile of patients on PD and possibly improve long-term outcomes such as cardiovascular disease risk and death.

NCT ID: NCT01493934 Completed - Clinical trials for Type 2 Diabetes Mellitus

Development of a Fast Measurement Technique of Insulin Resistance in Human

GLUCIMAG
Start date: April 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular diseases. In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led to grow in a near future, because of the increase of diabetes mellitus and obesity prevalence. Actually, there is no simple tool to measure insulin resistance. The gold standard technique remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this technique render it unsuitable for routine clinical use. Many methods or index have been proposed to assess insulin resistance in human, but none have shown enough relevance to be used in clinical use. Within the investigators U877 INSERM team, the investigators previously performed in vivo biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose transport, radiolabelled with123 iodine, with and without insulin, on the one hand in genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the other hand in rats with acquired insulin resistance after a "fructose diet". The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose transport variations in insulin sensible organs. Then, the investigators developed a fast and simple imaging protocol with a small animal gamma camera, which allows the obtaining of an insulin resistance index for each organ, directly transferable to human. The investigators project is to transfer to human this measurement technique, perfectly validated in animal. The main goal of this monocentric phase I-II study is to evaluate the tolerance to the insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic patients. The investigators secondary goals will be to evaluate feasibility and reproducibility of the measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure insulin resistance.

NCT ID: NCT01488409 Completed - Insulin Resistance Clinical Trials

Effects of Acipimox on Mitochondrial Function in Obesity

Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to examine whether a medication called acipimox can improve your body's mitochondria. Mitochondria are the "power house" of the cell and make energy for your body. Obesity is associated with increased risk for developing diabetes. However, the investigators do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our body uses glucose and responds to insulin. Recent studies have shown that changes in mitochondria may be involved in the development of diabetes and may be affected by FFA. The investigators propose to improve the function of mitochondria in obese people with pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators will use state of the art techniques to evaluate the mitochondria, including a new magnetic resonance imaging (MRI) technique to measure function of mitochondria in muscle.

NCT ID: NCT01487993 Completed - Obesity Clinical Trials

Metformin in Obese Children and Adolescents

MetVoorMin
Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.