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Prediabetic State clinical trials

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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: NCT03609697 Active, not recruiting - Pre-diabetes Clinical Trials

A Community-based Weight Loss Programme for Chinese Overweight Adults With Pre-diabetes

Start date: August 10, 2018
Phase: N/A
Study type: Interventional

Type 2 diabetes (T2DM) is a serious chronic condition and one of the world's fastest growing health problems. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. Pre-diabetes is a prevalent and potentially reversible condition, which provides an important window of opportunity for the prevention of T2DM and its complications. This project aims to translate the evidence-based diabetes prevention strategies into a community setting to reduce diabetes risks in Hong Kong Chinese people with pre-diabetes .

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: NCT03575000 Not yet recruiting - Schizophrenia Clinical Trials

Bromocriptine for Patients With Schizophrenia and Prediabetes

Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

NCT ID: NCT03558867 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

PREDICT
Start date: June 5, 2018
Phase: N/A
Study type: Interventional

Prediabetes is a common condition in overweight individuals affecting approximately 35% of American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer. Appropriate blood glucose control is crucial in preventing pre-diabetes complications and onset of diabetes, yet clinical practice, backed by randomised trials, reports that many patients treated with standard dietary guidelines or with the first-line treatment of diabetes patients, metformin, do not improve blood glucose control sufficiently. The overarching goal of the present project is to improve the efficacy of metformin mono-therapy in pre-diabetes and early type 2 diabetes.

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.