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Prediabetic State clinical trials

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NCT ID: NCT01932866 Completed - Pre-diabetes Clinical Trials

Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence

IDEA
Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this randomized, controlled study is to evaluate whether the knowledge of a personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle change program in prediabetic patients. The intervention group will receive diabetes risk score results at the beginning of the twelve weeks, and the control group will not receive these results. Both groups will review their baseline and 12-week diabetes risk score results at the conclusion of the program and will be followed for an additional twelve weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between the groups.

NCT ID: NCT01926457 Completed - Prediabetes Clinical Trials

Treating Prediabetes in the First Trimester

Start date: July 2013
Phase: N/A
Study type: Interventional

The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive intervention immediately upon diagnosis of prediabetes whereas the third trimester group will receive only routine prenatal care until 28 weeks at which time they will receive intervention. Intervention is defined as: - diabetes education - blood glucose monitoring - medications as needed - growth ultrasounds - antenatal testing The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's umbilical cord blood. The investigators hypothesize that women who undergo the above intervention in the first trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th percentile, and that the neonates will have lower fat mass, and weight-for-length at 12 months. The investigators further hypothesize that a greater proportion of patients undergoing first trimester intervention will have appropriate maternal gestational weight gain as defined by the Institute of Medicine, and a greater proportion will return to prepregnancy weight within 12 months.

NCT ID: NCT01910051 Completed - Prediabetes Clinical Trials

Explorative Assessment of Biomarkers in Overweight and Obese Subjects

Start date: September 25, 2013
Phase:
Study type: Observational

The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.

NCT ID: NCT01895179 Completed - Insulin Resistance Clinical Trials

Comparison of Time-Restricted Feeding Versus Grazing

TIMED EATING
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels. The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.

NCT ID: NCT01890876 Completed - Diabetes Clinical Trials

Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men

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

Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500 - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance considering the increasing number of persons suffering from impaired glucose tolerance or diabetes and the unique opportunities provided by the mountainous regions of the Alps to perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between 1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6 (IL-6), which is predominantly derived from the contracting limbs and may support the maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with acute and chronic altitude exposure at least partly mediated via adrenergic stimulation. Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and differences in serum IL-6 concentrations might help to explain distinctions between responses of glucose metabolism to CE and EE at low and moderate to high altitude. 32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma concentration will be performed pre, mid (day 5) and post intervention. Moreover anthropometric, strength and exercise capacity characteristics will be performed pre and post intervention. We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in normoxia.

NCT ID: NCT01889810 Completed - Insulin Resistance Clinical Trials

Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study

Start date: August 2013
Phase: N/A
Study type: Interventional

Insulin resistance is a state where the body does not respond as it should to the insulin it produces. Individuals who are insulin resistant are at increased risk of both heart disease and type 2 diabetesÍž importantly, diabetes more than doubles the risk of heart disease, independent of other recognised risk factors. Interventions that prevent or reverse insulin resistance may help to attenuate risk of heart disease and diabetes. A number of randomised controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin D on insulin resistance and other cardiovascular risk markers but experts have stated that further studies are required. Importantly, these studies should use appropriate endpoints, provide a high enough dose of vitamin D to optimise vitamin D status, and they should be conducted in clearly defined populations, The vitamin D trial we propose addresses these issues and aims to evaluate a potentially straightforward and low cost health care intervention for populations at highrisk of heart disease and diabetes. Specifically, this study would provide clinically relevant information on the metabolic effects of optimising vitamin D status in these high risk patients. This has clear economic and social implications given the current, and projected, burden of heart disease and diabetes. This study will investigate the effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease using the gold standard euglycaemic hyperinsulinaemic clamp method.

NCT ID: NCT01884792 Completed - Prediabetes Clinical Trials

Effects of Standing on Glycemia in Prediabetic Adults

Start date: March 2013
Phase: N/A
Study type: Interventional

The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.

NCT ID: NCT01884545 Completed - Prediabetic State Clinical Trials

Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease

Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients. Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk markers. Participants in the two groups that include health coaching will be assigned to a trained certified health coach for a period of 6 months. The duration of the study is 12 months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys at 6 weeks and 3 month time points.

NCT ID: NCT01862029 Completed - Obesity Clinical Trials

Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

Start date: May 22, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Roflumilast is a drug used to treat chronic obstructive pulmonary disease (COPD). It is designed to help reduce lung inflammation. However, during testing, roflumilast also appeared to reduce high blood sugar levels in people with COPD and type 2 diabetes. Other tests showed that roflumilast also improved blood sugar levels in people who only had type 2 diabetes. Researchers want to see how roflumilast affects insulin and blood sugar levels in overweight or obese people who are not diabetic, but who have high blood sugar levels. Objectives: - To see how well roflumilast improves blood sugar and insulin levels in prediabetic overweight or obese individuals. Eligibility: - Individuals between 30 to 65 years old who are overweight or obese (body mass index of 24.9 to 39.9 kg/m2) and have elevated blood sugar levels. Design: - This study will last approximately 8 weeks. Participants will have approximately five study visits over about 7 weeks. Two of these visits will be overnight inpatient stays. - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have a 3-day diet and exercise assessment with a dietitian. - In Week 1, participants will have a special diet for 2 days to keep their regular weight. They will then have a 2-day inpatient stay. During their stay, they will have multiple tests, including blood sugar tests and full body scans. They may provide a fat and muscle tissue biopsy sample. They will then receive the study drug to take during the study. - In Week 2, participants will repeat the diet study from the screening visit. They will receive a different dose of the study drug. - In Week 3, participants will review their diet results and have blood and urine tests. - In Week 5, participants will repeat the diet and exercise study from the screening visit. - In Week 6, participants will repeat the inpatient studies and tests from Week 1. In the last week, participants will have a final follow-up visit.

NCT ID: NCT01860599 Completed - Prediabetes Clinical Trials

Effects of Aerobic Exercise in Patients With Pre-diabetes

Start date: March 2010
Phase: N/A
Study type: Interventional

It is well known that diabetes and excessive or high blood sugars causes blood vessel and blood cell damage. It is also possible, then, that people with pre-diabetes may also start to have blood vessel and blood cell damage as the blood sugars rise from the normal range into the diabetic range. In addition to looking at potential damage, the question is whether or not this damage improves with exercise. This study aims to look at blood vessel and blood cells in three different ways by 1) looking at how the blood vessel responds to "sheer force" (a blood pressure cuff pumped up and then released after a few minutes). This is done by ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation and 3) By looking at certain blood cells in the lab, how long they live and the number of cells left after a certain number of days, and again, if this improves with exercise.