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Prediabetic State clinical trials

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NCT ID: NCT03230123 Recruiting - Diabetes Mellitus Clinical Trials

Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)

BIOMEL
Start date: May 2016
Phase: N/A
Study type: Interventional

Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo, 2015. According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a heterogeneous group of metabolic disorders associated with microvascular complications, hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it is estimated that the world population with diabetes is 382 million people and it is expected to reach 471 million in 2035. About 80% of individuals with diabetes live in developing countries where the epidemic has greater intensity. In the Diabetes Control and Complications Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~ 7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as starch and products of its hydrolysis are not absorbed in the small intestine. The green banana presents significant levels of RS, and it is considered a source for the intake of this substance. These foods have physiological functions in the intestinal regulation in glycemic control and delayed gastric emptying. To our knowledge, there are no long-term studies with DM to prove the benefits of resistant starch use. The objective of this study is to assess the benefits of green banana biomass consumption by patients with Pre DM and DM. Considering the possibility of improving glucose, lipid profile, increasing the secretion of glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers IL-6, PCR.

NCT ID: NCT03222765 Recruiting - PreDiabetes Clinical Trials

Prevention of Microvascular Complications in Prediabetes e-PREDICE Study

ePREDICE
Start date: March 15, 2015
Phase: N/A
Study type: Interventional

Background: A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia. Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early intensive management of hyperglycaemia with linagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both). Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised, partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2 placebo tablets/day; 2) LSI + 2 Metformin tablets of 850 mg/day; 3) LSI + 1 Linagliptin tablets of 5 mg/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of Linagliptin 2.5mg and Metformin 850 /day. Active intervention will last for at least 2 years. Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 14 clinical centres from 10 countries: Australia, Austria, Bulgaria, Greece, Italy, Kuwait, Poland, Serbia, Spain and Turkey and . (N=1000) Main Outcomes: The primary endpoint is a combined continous variable: "the microvascular complication índex" (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after randomisation. In addition, serological biomarkers of inflammation, vascular damage, non-alcoholic fatty liver disease, insulin secretion, measures of quality of life, sleep quality, neuropsychological evaluation and endothelial function will be also evaluated in a subset of participants.

NCT ID: NCT03211182 Recruiting - PreDiabetes Clinical Trials

Lifestyle Modification Intervention in Pre-diabetic Subjects

Start date: March 7, 2012
Phase: N/A
Study type: Interventional

The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

NCT ID: NCT03194009 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

PRuDENTE
Start date: August 10, 2017
Phase: N/A
Study type: Interventional

The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.

NCT ID: NCT03140865 Recruiting - Clinical trials for Mild Cognitive Impairment

Wake Forest Alzheimer's Disease Clinical Core

ADCC
Start date: January 2014
Phase:
Study type: Observational [Patient Registry]

Efforts to find treatments for AD have yielded only modest benefits, likely because longstanding AD pathological processes induce irreversible neurological compromise. These processes begin years before the onset of clinical symptoms. This possibility has been incorporated into a model describing stages of AD development, articulated by the NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the best hope for countermanding the effects of AD lies in intervening at the earliest possible point in the pathological cascade. There are several important ongoing efforts in adults with preclinical AD that directly target amyloid aggregation. Although this strategy addresses an important aspect of the AD pathological cascade, we believe that addressing metabolic dysfunction affecting glucose and insulin regulation offers a complementary approach, in that it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health, brain metabolism, tau regulation and neurovascular function. The purpose of the ADCC is to identify and characterize early risk factors that predict cognitive decline and dementia in asymptomatic adults and adults with early signs of cognitive impairment. The data obtained from this study, collected at enrollment and follow-up will allow us to examine disease trajectory in individuals with and without prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees, who will be well-characterized with regard to cognitive and metabolic status through ADCC assessments, will provide an important resource for other local (institution) and national investigations. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.

NCT ID: NCT03096002 Recruiting - PreDiabetes Clinical Trials

Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes

Start date: June 12, 2017
Phase:
Study type: Observational

The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise and lifestyle change program with brief counseling, will be more adherent to regular exercise one year after program completion compared to before they took part in the program.

NCT ID: NCT03049839 Recruiting - Prediabetic State Clinical Trials

Evaluation of a Community Health Program for the Prevention of Type 2 Diabetes and Other Cardio-metabolic Risk Factors in Adults: Districts of Barranquilla and Bogota, Colombia - January 2017 - December 2019

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

The main aim of this study is to evaluate the feasibility and effectiveness of a program for modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors in adults with different categories of risk from the primary health care strategy. The project will show the effect of these interventions for the first time in people With different risk of developing type 2 diabetes throughout the life in populations living in Colombia Located in 2 different cities, one of them in the interior of the country (districts of Bogota) and another in the north coast (districts of Barranquilla) .

NCT ID: NCT03022682 Recruiting - Obesity Clinical Trials

Inflammation, Diabetes, Ethnicity and Obesity Cohort

IDEO
Start date: February 2015
Phase:
Study type: Observational

Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.

NCT ID: NCT02981121 Recruiting - PreDiabetes Clinical Trials

Hospital-based Diabetes Prevention Study in Korea

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.

NCT ID: NCT02969798 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.