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Glucose Intolerance clinical trials

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NCT ID: NCT01839448 Completed - Type 2 Diabetes Clinical Trials

Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

DG Post-Partum
Start date: March 27, 2014
Phase: N/A
Study type: Observational

The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

NCT ID: NCT01831921 Completed - Obesity Clinical Trials

Latinos Combating Diabetes

La Comunidad
Start date: January 2014
Phase: N/A
Study type: Interventional

The investigators plan to test two different strategies for weight loss and diabetes prevention in the Latino community in and around Forsyth County, North Carolina. The study is designed to test the hypothesis that a lifestyle weight-loss program implemented within the Latino community will have a more beneficial and clinically meaningful impact on hemoglobin A1c (HbA1c), insulin metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care condition. This lifestyle intervention will include group-based sessions promoting healthy eating, increased physical activity and weight loss. These sessions will be delivered by lay community members, known as Latino Health Advisors (LHAs). The enhanced usual care group will consist of individual counseling with are registered dietitian and uses existing community resources to assist participants in making healthier lifestyle choices.

NCT ID: NCT01823367 Completed - Pre-diabetes Clinical Trials

Encourage Healthy Families

Encourage
Start date: December 2012
Phase: N/A
Study type: Interventional

This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.

NCT ID: NCT01795833 Completed - Prediabetes Clinical Trials

Diabetes Prevention Using SMS Technology

Start date: June 3, 2013
Phase: N/A
Study type: Interventional

Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent clinical trials have demonstrated that it may be prevented by lifestyle intervention focused on diet and physical activity. These trials have been expensive and labour intensive and this has limited translation of the known benefits to the population at large. We propose using a mobile phone intervention for lifestyle change and will assess it in a clinical trial(study) in people with impaired glucose regulation (high risk at developing type 2 diabetes). The study will be conducted in both India and the UK. The purpose of the study is to assess the effectiveness and acceptability of a text messaging system to prevent the progression to diabetes in people with high risk. The study involves five visits to clinic over 2 year period. Study participants will be divided into two groups by the computer generated random method - one is 'Usual Care' group and the other 'Text Messaging' group. - Usual care will consist of a 30 minute interview, delivering personalized diet and exercise advice, supplemented by written material and education regarding diabetes. This will be delivered once at the beginning of the study. - The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalized to individual targets set at the initial interview. The primary outcome will be progression to diabetes, with and without SMS intervention. Secondary outcomes will be improvements in physical activity (reported and directly measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL cholesterol and serum triglycerides).

NCT ID: NCT01777893 Completed - Obesity Clinical Trials

Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes

PREVIEW
Start date: June 2013
Phase: N/A
Study type: Interventional

Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been initiated to find out the most effective lifestyle-components (diet and physical activity) in the prevention of Type-2 diabetes. The project consists of a randomized lifestyle-intervention with the more specific aim to determine the preventative impact of a high-protein and low-GI diet in combination with moderate or high intensity physical activity compared with a moderate-protein and moderate GI diet in combination with the same activity levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and older adults. The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain, Netherlands, UK) and Australia and New Zealand. A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and adolescents aged 10—18 y) will be recruited. All adult participants are first treated by a low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and adolescents are treated separately with a conventional weight-reduction diet, with-out a specific aim for absolute weight loss. The adult participants are randomized into two different diet interventions and two exercise interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by weight-maintenance (prevention of relapse in reduced body weight) and by independent metabolic effects of diet and physical activity. The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3 years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI, adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c. For children and adolescents: Change in insulin resistance at 2 years after randomization to high protein versus moderate protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as well as physiological improvement of health with respect to pre-diabetic characteristics. Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2 diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity physical activity will be superior compared to moderate-intensity physical activity.

NCT ID: NCT01773707 Completed - Type 1 Diabetes Clinical Trials

CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.

NCT ID: NCT01771380 Completed - Clinical trials for Impaired Glucose Tolerance

Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Start date: February 2013
Phase: N/A
Study type: Observational

In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free fraction that is biologically active. Polymorphisms in DBP are related to the serum level of 25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound) 25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as to the RNA expression in peripheral blood to evaluate the biological importance of the free versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D supplementation study to participate in the study which will be one visit only and include collection of blood samples.

NCT ID: NCT01765946 Completed - Aging Clinical Trials

Metformin and Longevity Genes in Prediabetes

Start date: June 2010
Phase: Phase 4
Study type: Interventional

Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased cardiovascular risk and reduced life expectancy, as compared to the general population. AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin) and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to describe the effects of the AMPK pathway on longevity genes and inflammation in the setting of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2, CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells. Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined. In the in vitro study the investigators will evaluate the effects of AMPK activation or inhibition on longevity gene and protein expression.

NCT ID: NCT01763346 Completed - Obesity Clinical Trials

Beta Cell Restoration Through Fat Mitigation

BetaFat
Start date: June 2013
Phase: N/A
Study type: Interventional

Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes.

NCT ID: NCT01754792 Completed - Healthy Clinical Trials

Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects

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

The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects. This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.