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Prediabetic State clinical trials

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NCT ID: NCT03644524 Completed - Obesity Clinical Trials

Heat Therapy and Cardiometabolic Health in Obese Women

CMH
Start date: September 8, 2015
Phase: N/A
Study type: Interventional

Traditional medical treatments are often based on research done exclusively in males, and recent research efforts in the physiology community have highlighted critical sex differences in disease presentation and progression. For example, the relative risk of fatal heart disease is 50% greater in obese, diabetic women as compared to their male counterparts, and women appear to respond differently to lifestyle interventions such as exercise compared with men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental therapeutic potential for improving cardiovascular and metabolic health in obese women. In addition, passive heat exposure may offer specific cellular protection from stresses like a lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease. This study is investigating the possible cardiovascular and metabolic health benefits of chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10 weeks) may reduce obese womens' cardiometabolic risk. The investigators are examining cardiovascular health through blood pressure, blood vessel stiffness, sympathetic ('fight or flight') activity, and responsiveness to stresses like increased or decreased blood flow. The investigators are also examining metabolic health through an oral glucose tolerance test and a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward the specific health needs and complications of obese women, in an effort to improve cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk population.

NCT ID: NCT03617757 Completed - Clinical trials for Progression From Impaired Fasting Glucose to Diabetes Mellitus

Progression From Impaired Fasting Glucose to Diabetes Mellitus Among Chinese

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Impaired fasting glucose (IFG), a significant risk factor for diabetes mellitus (DM), is commonly encountered in the primary care setting and represents an important target for DM prevention. However, data on the long term risk of progression from IFG to DM among Chinese subjects and associated risk factors are currently lacking; appropriate DM prevention programme for this group cannot be yet established. This is a prospective cohort study that aims to estimate the incidence of progression to diabetes mellitus (DM) among Chinese primary care patients with impaired fasting glucose (IFG) over a 3-year period and evaluate putative risk factors. A prospective cohort of around 700 non-diabetic Chinese adults who had IFG (i.e. fasting glucose level between 5.6 to 6.9mmol/L) and received baseline assessment between May 2013 and March 2015 at 3 public primary care clinics across Hong Kong will be invited for a 36-month-follow-up glycaemic status assessment (i.e. to repeat 75-gram oral glucose tolerance test (OGTT) and HbA1c test). The OGTT results will be used as the gold standard for the diagnosis of DM, normoglycaemia, IFG and impaired glucose tolerance (IGT) state. Demographics and lifestyle of the subjects including age, gender, occupation, education level, socio-economic status, smoking and drinking history, diet, exercise, work-sleep pattern, stress, quality of life and family history will be collected using standardized questionnaire. Participant's medical history and drug history will be retrieved from the Clinical Management System (CMS) of the Hospital Authority. Lipid profile, blood pressure, waist circumference and body mass index will also be assessed. Logistic regression model will be performed to determine if these variables are associated with progression from IFG to DM. The primary outcome is the incidence of DM among the IFG study population. The secondary outcomes are the risks of developing DM among subjects with isolated IFG or combined IFG/IGT and determinants of progression to DM. Knowledge on the natural history of isolated IFG or combined IFG/IGT among Hong Kong Chinese primary care patients and the significant modifiable associated risk factors for progression to DM will enable primary care researchers to design optimal management programme for diabetes prevention among these high risk patients.

NCT ID: NCT03616275 Completed - Prediabetes Clinical Trials

Enhancing the Vagal Tone in Prediabetes Individuals

Start date: October 17, 2017
Phase: N/A
Study type: Interventional

This is a 2-year course of study. A randomized control trial will be conducted, in which 90 prediabetes individuals will be recruited and randomly assigned them into the wait-list control group or experimental group to test the effectiveness of 8 once-a-week, individual, 20-min sessions of HRV biofeedback on modulating vagal tone, glycemic control, psychological wellbeing, and inflammatory status in this population. Its longitudinal effects will be evaluated after 3- and 6-month follow-up.

NCT ID: NCT03612037 Completed - PreDiabetes Clinical Trials

Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans. The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.

NCT ID: NCT03591900 Completed - Diabetes Clinical Trials

The Use of CGMS to Detect Alterations of Blood Glucose in Thalassemic Patients

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

The aim of the study is to: - Assess the pattern of glucose homeostasis in patients with B thalassemia . - To detect early impairment in glucose metabolism and prediabetic state in B thalassemia patients using continuous glucose monitoring system. - To study the prevalence and type of DM in B thalassemia patients. - A comparative study of standard insulin therapy compared to insulin pump therapy in thalassemic diabetic patients will be done. The study will include screening of 200 children and adolescents who are regularly attending the Hematology Oncology Clinic and fulfilling the inclusion criteria for abnormalities of glucose homeostasis. A pilot study will be done on 15 patients with abnormal glucose tolerance which will include: A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration . B-Therapeutic intervention: Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to • Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy.

NCT ID: NCT03577119 Completed - Pre-Diabetes Clinical Trials

Full-fat Yogurt and Glucose Tolerance

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

This study determines if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can reduce the risk of type 2 diabetes and inflammation in association with changes in the composition of the gastrointestinal bacteria prediabetic male and female volunteers. The central hypothesis is that dairy fat impacts whole body glucose handling and insulin sensitivity as well as inflammation both directly, and indirectly via influencing the gut microbiota composition.

NCT ID: NCT03557541 Completed - Clinical trials for Diabetes Mellitus, Type 2

Sardine-enriched Diet for Prevention Type 2 Diabetes

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

The hypothesis formulated is that 200 g of sardine on a weekly basis will have a favourable impact avoiding the natural development of the pathology due to changes in the biochemical profile, the anthropometrics, inflammatory markers, changes in gut microbiota populations, also in transcriptomics and metabolomics.

NCT ID: NCT03553030 Completed - PreDiabetes Clinical Trials

Prediabetes and Non Obstructive Coronary Atherosclerosis.

Start date: January 1, 2015
Phase:
Study type: Observational

Objectives: Prediabetes may condition an early endothelium dysfunction, and the development of non obstructive coronary stenosis (NOCS). Indeed, authors' study aim was to investigate the endothelial dysfunction, and Major Adverse Cardiac Events (MACE) in prediabetics vs. normo glycemic subjects. Materials and Methods: 308 patients with evidence of left anterior descending (LAD) coronary NOCS (<50% luminal stenosis), will entere prospectively into a database. After assessment of endothelial coronary dysfunction by acetilcoline infusion, 86 propensity score matched (PSM) prediabetics and 86 PSM normoglycemics will be consecutive enrolled in the study.

NCT ID: NCT03544320 Completed - Pre-Diabetes Clinical Trials

Prediction Using Connected Technologies for Diabetes

PREDICT-DM
Start date: July 9, 2018
Phase: N/A
Study type: Interventional

In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

NCT ID: NCT03536364 Completed - Obesity Clinical Trials

Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.