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Overweight clinical trials

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NCT ID: NCT04943926 Recruiting - Hypertension Clinical Trials

Dietary Strategies for Remission of Type 2 Diabetes

CARBCOUNT
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

NCT ID: NCT04941651 Recruiting - Clinical trials for Overweight and Obesity

Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

TOOLBAR
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels. Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support. In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor. A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.

NCT ID: NCT04938544 Recruiting - Insulin Resistance Clinical Trials

Determination of Insulin-stimulated Hepatic Glucose Uptake by PET-CT Measurements

ISGU
Start date: August 1, 2021
Phase:
Study type: Observational

In the absence of excessive alcohol consumption, increased levels of fat in the liver (>5%) are diagnosed as non-alcoholic fatty liver (NAFL). It has been shown that NAFL is strongly associated with impairments in metabolic health such as hepatic and whole-body insulin resistance. Insulin resistance is seen as the earliest hallmark in the development of type 2 diabetes. Insulin has two main effects on the liver: suppressing endogenous glucose production (EGP) and increasing glucose uptake. While the former has been extensively studied and is known to be impaired in NAFL, no studies have yet examined whether insulin-stimulated hepatic glucose uptake is affected by NAFL. Recent methodological developments allow us to visualize and quantify glucose uptake in any given tissue using dynamic Positron Emission Tomography (PET) with 18Fluorinated glucose tracer (FDG) during insulin stimulation. In the present study, we will in a first instance optimize the insulin-stimulated whole-body PET protocol and apply the dose as reported in the literature 4 megabequerels per kg of body weight (MBq/kg) (±8 mSv) in the first three subjects. It will then be evaluated whether the dose can be decreased in the remaining measurements. Another twelve individuals will then undergo the optimized dynamic PET protocol to assess insulin-stimulated hepatic glucose together with whole-body glucose uptake measures. Liver fat content and composition will be assessed by proton magnetic resonance spectroscopy (1H-MRS). Fasted De Novo Lipogenesis (DNL) will also be measured by deuterated water. Additionally, a two-step clamp will be performed to measure whole-body insulin sensitivity and insulin-stimulated suppression of EGP. The identification of the contributing factors to insulin resistance during the development of NAFL is crucial in order to develop more effective strategies for the prevention and treatment of metabolic disorders.

NCT ID: NCT04933188 Recruiting - Clinical trials for Overweight and Obesity

Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)

Start date: May 1, 2019
Phase:
Study type: Observational

This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.

NCT ID: NCT04932174 Recruiting - Overweight Clinical Trials

High Intensity Interval Training Versus Low-intensity Continuous Training on Physical Fitness Among Overweight Adult

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.

NCT ID: NCT04931017 Recruiting - Lung Carcinoma Clinical Trials

Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer

Start date: September 9, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients' immune system learn ("reprogram") to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development.

NCT ID: NCT04924504 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Mechanisms Behind Severe Insulin Resistance During Pregnancy in Women With Glucose Metabolic Disorders (SIR-MET)

Start date: May 1, 2021
Phase:
Study type: Observational

The aim of this study is to describe the metabolic changes during pregnancy in women with type 2 diabetes or gestational diabetes in order to detect the pathophysiological mechanisms behind severe insulin resistance during pregnancy as well as the short- and long term consequences for mother and child. Included pathophysiological mechanisms potentially associated with severe insulin resistance are: Maternal hormonal, inflammatory and metabolic markers in the blood, as well as the level, content and bioactivity of exosomes and genetic variants associated with overweight and diabetes. In addition to the analysis on maternal blood, the same analysis will be performed on umbilical cord blood in order to determine the correlation between markers associated with insulin sensitivity in maternal and umbilical blood. Furthermore, fetal metabolic changes influence on fetal growth and development will be evaluated. Postpartum, the breast milk will also be examined for metabolic active substances that could influence the newborns growth and metabolism. Investigating one potential short-term consequence of diabetes during pregnancy, the association between insulin resistance and structural and functional changes in the placenta will be examined as well as the consequences of such changes on fetal growth and development. Investigating one potential long-term consequence of diabetes during pregnancy, the association between treatment with high doses of insulin during pregnancy and the future risk of developing cardiovascular diseases and heart failure will be examined.

NCT ID: NCT04919876 Recruiting - Clinical trials for Mitochondrial Functions

Phytochemicals on "Metabolic Aging" in Older Overweight Adults

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

Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases. It is manifested partly by a progressive decline in fitness and an increase in death. The key to healthy aging is a healthy lifestyle, including eating a variety of healthy foods and frequently participating in physical activities. Supplements made from widely consumed plant products have the potential for promoting healthy aging. However, more human data is required to substantiate this potential. Thus, the purpose of this study is to determine examining whether older adults taking a fruit/vegetable supplement for 6 weeks will have biochemical values of stool, blood, and urine similar to those of younger adults. The fruit/vegetable supplement contains a variety of vitamins and minerals and other nutrients that have been known to be beneficial to human health and many Americans may consume inadequate amounts in their daily diet. In order for us to understand how these nutrients may benefit health, we are interested in determining whether they can modify biochemical values of blood that occur in the body after taking the supplement for 6 weeks. We aim to have 40 older subjects and 20 younger subjects complete the trial. The enrolled subjects will consume prepackaged study meals for approximately 8 weeks and provide blood samples. The study meals will comprise foods most Americans eat every day. The older subjects, but not younger subjects, will take the assigned supplement. The younger subjects will consume the study meals for 2 weeks and provide one blood sample during the study.

NCT ID: NCT04919603 Recruiting - Physical Activity Clinical Trials

Impact of Exercise Intervention on the Phenome

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.

NCT ID: NCT04918732 Recruiting - Clinical trials for Cardiovascular Diseases

NAFLD Primary Care

Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), cardiovascular diseases (CVD) and increased risk of cancer development. NAFLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from non-alcoholic fatty liver (NAFL) to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% non-alcoholic steatohepatitis (NASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, there is a striking lack of awareness on all levels of NAFLD. Furthermore, little to know data are available concerning the quality of life of NAFLD patients. Additionally, the majority of NAFLD patients are currently not detected due to the lack of non-invasive methods to diagnose NAFLD. Most of these patients, as a first contact in the healthcare system, will be found in the outpatient clinic of the general practitioner (GP). To date, it is not clear what the burden is of NAFLD and related diseases in at risk subjects in primary care. Therefore, identification of NAFLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health.