IMPACT Intervention
Diabetes MellitusType 2Introduction : The prevalence of type 2 diabetes is increasing in France, especially in deprived districts. The Itineraires Medico-sociaux Programme d'Accompagnement sur un Territoire (IMPACT) intervention is intended for disadvantaged patients with a chronic disease (not only type 2 diabetes). The IMPACT intervention offers coordinated and patient-centered care by a multidisciplinary team with an empowerment approach. This personalised intervention lasts 6 months. This study aims to evaluate the effect of 6 months IMPACT intervention on glycaemic control (glycated haemoglobin - HbA1c) of patients with type 2 diabetes in deprived districts. Method : This will be a randomised, controlled, parallel group, multicenter, open-label trial. 140 adults with type 2 diabetes will be randomised in two arms : IMPACT intervention group (n : 70) and usual care group (n : 70). The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model.
Effect of a Dietary Intervention on Intracellular Lipid Levels, Insulin Sensitivity, and Glycemic...
Diabetes MellitusType 2The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on changes in intramyocellular and hepatocellular lipid content in adults with type 2 diabetes. Changes in insulin sensitivity and glycemic control will also be assessed in this study. The study duration is 44 weeks.
The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly...
Diabetes MellitusDiabetes7 moreThe aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.
The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial...
Diabetes MellitusType 23 moreThe incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
ObesityOverweight5 moreThe present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control
Diabetes MellitusType 2Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending. The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2. In the majority of patients their follow-up is carried out from primary care, where they occupy a third of the visits, it is a main reason for consultation. The mobile phone is becoming an interesting tool for therapeutic education. The objective: To decrease the HbA1c value by 10% in patients who have their HbA1c >9% and 0.5% in those who have an HbA1c value <9%-Reduce the number of spontaneous visits in nursing consultations. Know the attitude and motivations of the patients participating in the study It will be a probabilistic randomized intervention study at the Mas Font Primary Care Center in Viladecans (Barcelona). According to medical history as of December 31, 2020, there were 1554 patients diagnosed with DM2, 402 DM2 patients with poor control (HbA1c >8%) Patients who meet inclusion criteria will be contacted by telephone or at consultations and will be offered to participate and sign consent. They are then automatically randomized to intervention or control group. Study participants will be visited in person every six months and both groups will follow the center's protocol in face-to-face visits, The intervention group will be reinforced with a fortnightly telephone visit.
Baseline Oral Health Study: UnCoVer the Connections to General Health
Cardiovascular DiseasesDiabetes Type 2Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering. Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes
Type 2 Diabetes MellitusThe main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus.
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D...
Type2 DiabetesNASH - Nonalcoholic Steatohepatitis2 moreThis is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
Face-it: Health Promotion for Women With Prior Gestational Diabetes
Gestational DiabetesType 2 Diabetes Mellitus1 moreThis project focuses on evaluating a health promotion intervention among families where the mother has prior gestational diabetes mellitus (GDM) in the first year after delivery. The intervention focuses on the individual, family and health system levels. The aim is to increase quality of life and reduce the risk of type 2 diabetes among women with prior GDM and their families.