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102 active trials for Type2 Diabetes

Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes (VITAL)

The purpose of the study is to evaluate the effect of the WW program on people with Type 2 diabetes and the effect on glycemic control. This study will be a 6 month prospective, single arm clinical trial coordinated by Pennington Biomedical Research Center. Up to 150 participants will be recruited across 3 sites. Participants will have Type 2 diabetes and overweight/obesity.

Start: March 2021

Effects of Fructose/Glucose-rich Diet on Brown Fat in Healthy Subjects (GB7)

Activating brown and beige adipose tissue (herein described as BAT) has been recently recognized as a potential means to increase energy expenditure and lower blood glucose, however, BAT activity appears to be reduced with obesity, aging or Type 2 Diabetes (T2D). BAT has the unique capability to burn large amounts of sugar and fat and effectively dissipate this energy as heat due to the expression of uncoupling protein 1 (UCP1) which is controlled by a thermogenic gene program of transcription factors, co-activators and protein kinases. Thus, enhancing the thermogenic gene program may be beneficial for treating obesity and T2D. Despite the importance of BAT in regulating metabolism our understanding of the factors which suppress its metabolic activity with obesity, aging and T2D are largely unknown. Recently, it was shown that peripheral serotonin, which is regulated by the tryptophan hydroxylase 1 (Tph1), is a negative regulator of BAT metabolic activity. In addition to serotonin, other studies have indicated that pro-inflammatory stimuli may also inhibit BAT metabolic activity. These data suggest that reduced activation of BAT may be due to increases in peripheral serotonin and inflammation. Importantly, the gut microbiome has recently been recognized as an important regulator of serotonin and inflammatory pathways suggesting the observed effects of the microbiome on obesity, T2D may be mediated in part through reductions in BAT activity. One mechanism by which the environment may impact BAT activity and the thermogenic gene program over the last 3 decades involves changes in our food supply as result of changes in agricultural production (chlorpyrifos, glyphosphate) and the addition of food additives (fructose). These agents have been reported to alter inflammation, serotonin metabolism and the gut microbiome indicating a potential bimodal (direct and indirect via the microbiome) mechanism by which they may alter the thermogenic gene program and contribute to chronic metabolic disease. Thus, our overarching hypothesis is that environmental agents and additives related to food production may contribute to the reduced metabolic activity of BAT. The objective is to identify and characterize how food production agents and additives reduce the metabolic activity of BAT.

Start: May 2017

Cardiovascular Risk and Functional Responses From Dancing at Home in the Elderly With and Without Type 2 Diabetes

The goal of this randomized controlled trial is to investigate the effects of a dance intervention performed at home, on cardiovascular risk factors and functional capacity of elderly individuals with and without type 2 diabetes mellitus. Comparison will be performed with a walking exercise intervention, performed outside. Dance sessions will be guided online by an expertise instructor, and walking sessions will be performed at a self-selected intensity, with no simultaneous supervision. All participants will complete an exercise diary after each exercise session (reporting perception of subjective effort, affective responses, and others).The participants will include men and women between 65 and 80 years old, with body mass index inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and power, balance, gate ability, etc). Cognitive skills (executive function and memory) will be also assessed. The experimental design will include a control period of four weeks, two sessions of assessments before and after the interventions, and twelve weeks of dancing or walking interventions, performed three times a week, in non-consecutive days, with 60 min duration.

Start: May 2021

An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol

ORION-3 is a Phase II, open-label, non-randomized, active comparator extension trial to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).

Start: March 2017

Identification and Validation of Noninvasive Biomarkers of the Diagnosis and Severity of NASH in Type 2 Diabetics

Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment. QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and /or extensive clinical-biological phenotyping data; and/or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement these phenotyping data. This approach will also enable us to improve our understanding of pathophysiology (new signaling pathways, new therapeutic targets).

Start: October 2018

Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults

Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities. Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP) Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs. RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change. The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults.

Start: February 2019

Hypoglycemia and Autonomic Nervous System Function- B2

We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.

Start: September 2017

Effect of Ertugliflozin on Cardiac Function in Diabetes

The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.

Start: June 2019

Influence of Preprandial Metformin Administration on Carbohydrate Absorption

Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption. It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake. To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.

Start: July 2021

A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

This is a Phase 1, first in human (FiH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, PK and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). The study will be conducted in 2 Parts (Part A and B), with 4 cohorts included in each part (Part A; Cohorts A1 to A4 and Part B; Cohorts B1 to B4).

Start: February 2021

Alternative Lifestyle Interventions for Vulnerable Ethnic Groups

Black obese mothers are vulnerable to pregnancy complications such as gestational diabetes mellitus (GDM). This ultimately elevates her risk of Type 2 diabetes mellitus (T2DM) which increases her cardiovascular risk. The post-partum period or "fourth trimester" may be an ideal time to employ preventative strategies to alter her lifetime health-course. Unfortunately, black mothers are less likely to follow up post-partum, less likely to be screened for T2DM and less likely to be informed of the connection between pregnancy complications and cardiovascular risk. The Diabetes Prevention Program (DPP) is the "gold standard" for lifestyle intervention to prevent T2DM in at risk patients. However, the DPP underperformed in Black women and can be improved upon. The investigators propose a randomized controlled double blind trial entitled: Alternative Lifestyle Interventions for the Prevention of Vulnerable Ethnic groups or ALIVE. The ALIVE program will follow the Diabetes Prevention Program (DPP) curriculum as outlined by the CDC using an online platform. However, this program will expand on the DPP's educational program and provide trained community-based health care workers i.e doulas to administer post-partum support via telehealth for the first 12 weeks post-partum. Participants will be randomized to (1. Doula only x 12 weeks. 2. DPP only x 1 year or 3. ALIVE=doula+DPP). In order to understand the biology that accompanies GDMtoT2DM transition, the investigators will conduct concomitant, longitudinal assessment of DNA methylation patterns to identify differentially methylated genes important in the pathogenesis of T2DM. The investigators hypothesize that for Black participants with GDM, ALIVE will reduce incidence of T2DM at two years and give biological insight into the susceptibility of developing Type 2 DM using genome wide epigenomic profiling The investigators propose this randomized double blind controlled clinical trial utilizing institution and community partnerships to increase the rates of post-partum screening of T2DM in Black women with a pregnancy complicated with GDM. The investigators also will implement the ALIVE, a precision based approach to reduce and T2DM in Black women. The investigators will gain biologic insights by linking the epigenome to the clinical phenotypes. Our discoveries will be a forward leap in the quest to reduce cardiovascular risk contributed by GDM and T2DM that lead to maternal morbidity and mortality.

Start: June 2021

The Belgian Diabetes in Pregnancy Follow-up Study

Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. GDM is associated with increased risks for pregnancy complications such as macrosomia s and preterm delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM) within the next ten years after delivery. The children are also at increased risk of developing obesity and T2DM later in life. Studies are needed to find more accurate predictors for the metabolic risk later in life. This will help to individualize the follow-up and to develop tailored prevention strategies in women and offspring with a history of GDM. In this research project we will therefore investigate how the long-term metabolic risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375 women and offspring pairs 3-7 years after the delivery across different gestational glucose tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study whether a promising new biomarker, glycated CD59, is a good predictor for the long-term metabolic risk.

Start: January 2021

Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes

The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.

Start: March 2017

Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes. Primary hypotheses: After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect). After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively. After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

Start: January 2015

Liraglutide Effects on Epicardial Fat Inflammatory Genes

Epicardial adipose tissue (EAT) is the visceral fat of the heart. EAT could locally affect the coronary arteries through local secretion of pro-inflammatory cytokines. EAT plays a role in the development of the coronary artery disease (CAD). EAT is a highly enriched with genes involved in inflammation. Given its rapid metabolism and simple measurability, as first developed by Iacobellis, EAT serves as target for medications targeting the fat. Glucagon-like peptide-1 agonists (GLP-1A) are anti-diabetic medications with recently suggested cardio-protective properties. Liraglutide, a GLP-1A, has recently shown to reduce the cardiovascular risk. Iacobellis'group found that EAT thickness decreased by an unprecedented 36% after 12 weeks of treatment with liraglutide. Remarkably, Iacobellis'group found for the first time that human EAT express GLP-1 Receptor (GLP-1R). GLP-1A effects may be therefore visceral fat specific and target EAT. Based on these preliminary data, we hypothesize that treatment with liraglutide will significantly and rapidly reduce EAT inflammation. Decreased EAT inflammation can reduce the burden of the coronary plaques. We will test our hypothesis in a 12-week randomized, double-blind, placebo-controlled, interventional study in 40 patients with type 2 diabetes mellitus (T2DM), and CAD, with an acceptable glycemic control on their current diabetes regimen who require elective coronary artery bypass graft (CABG) regardless of their participation in the study. A minimum time frame of 4-week treatment will be considered to detect significant changes in the study endpoints. Inclusion criteria for body fat markers will rule out the confounding effect of different body fast distribution at baseline. Study subjects will be randomized in two groups of 20 patients to receive additional liraglutide or to remain on current treatment/ placebo prior to cardiac surgery. CAD subjects not allocated to liraglutide will be started on a supervised low calorie diet (LCD) to achieve approximately 5% of weight loss after from a minimum of 4 weeks up to 12 weeks to avoid the confounding effect of weight loss on the study outcomes. EAT samples will be collected during cardiac surgery and processed for analysis of mRNA and protein expression of EAT inflammatory genes such as Tumor Necrosis Factor-alpha (TNF-?) and Interleukin 6 (IL-6), and GLP-1R.

Start: September 2018

A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes

Further studies are needed to establish the optimal diet for treating T2D. The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver. 135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD) for 6 months. Measurements and investigations will be performed at baseline and after 6 months.

Start: November 2016

A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2

The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values.

Start: December 2020

Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk

Enhancing children's sleep duration and/or timing may represent a novel approach for weight regulation and prevention of T2DM. The proposed study will assess how experimental changes in children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African American children ages 8-11 years old who sleep approximately 9.5 hours or less each night will be enrolled into a 4-arm randomized controlled pilot to compare three experimental manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45 minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2- and 4-week follow-up, participants be weighed and measured for height, have body fat assessed (bod pod), and their blood drawn (following an overnight fast). The pilot will provide important data on the potential role of sleep in combating disparities in cardiometabolic risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose regulation and 2) to determine the effect of changes in sleep on additional measures of glucose regulation and adiposity.

Start: July 2017

Efficacy of a High-intensity Physical Activity Program on Renal Function in High Risk Patients With Type 2 Diabetes

Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy. It has been shown that the trajectory of renal function (estimated glomerular filtration rate - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic patients. However the clinical use of this prognostic marker is not associated to date with a clear therapeutic intervention, effective in patients with type 2 diabetes identified with this biomarker. In France, type 2 diabetes patients have twice less physical activity than non-diabetic persons. Recently, it has been published that physical activity was associated with an improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD study. It was demonstrated that high-intensity physical activity (HIPA) can have several additional advantages over moderate-intensity, on blood pressure improvement, and cardiovascular risk profile modification. In addition, this procedure was shown to be safe in patients with high cardiovascular risk. We plan to perform a randomized intervention comparing a structured program of high-intensity physical activity (HIPA) vs standard recommendations for physical activity on renal function decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety and quality of life (secondary outcomes). Study participants will be patients with established type 2 diabetes and a high renal risk, identified by rapid renal function decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned to last for 2 years.

Start: February 2018

A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH

This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.

Start: August 2021