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Insulin Resistance clinical trials

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NCT ID: NCT00845156 Completed - Insulin Resistance Clinical Trials

Alpha Lipoic Acid and Insulin Resistance

Start date: January 2008
Phase: N/A
Study type: Interventional

Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

NCT ID: NCT00843479 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Start date: June 2009
Phase: N/A
Study type: Observational

Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age. Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil. The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes.

NCT ID: NCT00843232 Completed - Clinical trials for Diabetes Mellitus, Type 2

Characterization of the Incretinpathy in Type 2 Diabetes Initiated After Sixty Years Old

Start date: July 2009
Phase: N/A
Study type: Observational

Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production, frequently accelerated gastric emptying and obesity. The known effects of the incretin hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in gastric emptying and modulation of the appetite. T2DM have disturbances in this system, providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert trophic effects on the beta-cell. Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents rests on their ability of to increase active (intact) levels of incretin peptides, including GLP-1 and GIP. Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil. T2DM in elderly are behaving differently. Elderly patients have no increase in liver production of glucose; when obese, have normal insulin secretion, however, display extreme resistance to its action. In non obese individuals, the concentration of glucose necessary for insulin secretion is increased and the action is standard. These findings suggest therefore that the approach should be differentiated treatment for these individuals.

NCT ID: NCT00841334 Completed - Obesity Clinical Trials

Adolescents Committed to Nutrition and Physical Activity

ACTION
Start date: May 2008
Phase: N/A
Study type: Interventional

Community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. The intervention will be implemented through school-based health centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. Students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.

NCT ID: NCT00835120 Completed - Metabolic Syndrome Clinical Trials

Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

Start date: March 2009
Phase: Phase 4
Study type: Interventional

The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.

NCT ID: NCT00833846 Completed - Diabetes Clinical Trials

Pilot Study of Mitochondrial Biology in Human Platelets

Start date: January 27, 2009
Phase: N/A
Study type: Observational

Type II diabetes mellitus is rapidly becoming a global pandemic with a deleterious impact on cardiovascular morbidity and mortality. Understanding its pathophysiology is important for the development of future therapeutic interventions. Emerging evidence suggests interplay between mitochondrial dysfunction and the development of insulin resistance. Interestingly, mitochondrial dysfunction in skeletal muscle and adipose tissue are early events in the development of type II diabetes mellitus and are proposed to play a role in exacerbating insulin resistance. Although it has been demonstrated that skeletal muscle of insulin-resistant individuals has reduced mitochondria and mitochondrial dysfunction, whether this disruption of mitochondrial function is more widespread has not been explored. We hypothesize that this disruption of mitochondrial function is more systemic and thereby may contribute to the development of peripheral insulin resistance and possibly promote the myriad of complications associated with diabetes. To test these assumptions, we propose an initial proof of concept study to evaluate mitochondrial biology in human platelets in normal volunteers, pre-diabetic and diabetic subjects to assess whether mitochondrial disruption/dysfunction evolves with the progression to type II diabetes. In parallel, proteomic analysis will be performed to evaluate whether the development of insulin resistance and diabetes confers a specific modulation in the biological signature of human platelets with disease progression. To delineate these concepts, we will evaluate study subject's glucose tolerance and insulin sensitivity and draw blood in parallel to study their platelets. Biological readouts will include: 1) the quantification of the mitochondrial proteome and electron transfer chain content; 2) the evaluation of platelet mitochondrial respiratory function and 3) to determine the mitochondrial reactive oxygen species capacity and defenses. If this hypothesis is validated, this study will show that the mitochondrial disruption/dysfunction is a more generalized finding in type II diabetes. Additionally, it would propose the use of platelets as potential biomarkers for early detection of mitochondrial function and assessment of disease. Finally, this would establish a peripheral blood readout of the modification of mitochondrial function as a novel approach to monitor the prevention and/or reversal of insulin resistance and diabetes in response to therapeutic strategies.

NCT ID: NCT00831779 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

NCT ID: NCT00823277 Completed - Hypertension Clinical Trials

Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight

Start date: January 2009
Phase:
Study type: Observational

Definition: the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity. The specific aims are to; - describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations). - investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content. (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic. (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content - Investigate the association between genetic variants and obesity.

NCT ID: NCT00820651 Completed - Insulin Resistance Clinical Trials

Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.

NCT ID: NCT00803296 Completed - Type 2 Diabetes Clinical Trials

Incretin Effect in Lean and Obese Subjects

BMI-INK
Start date: January 2006
Phase: N/A
Study type: Observational

The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.