Glucose Monitoring Comparison in Primary Care
Diabetes MellitusType 2This research trial will randomize 30 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
Type2 DiabetesBisphenol AThe aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients
Effects of Seaweed Extract on Blood Glucose Response to Sucrose
Glucose IntoleranceDiabetes Mellitus3 moreThis study will examine the impact of the seaweed (Ascophyllum nodosum) extract on blood glucose levels after a sugary drink in healthy subjects. The aim of this study is to investigate if the seaweed extract, when consumed with the sucrose, can lower blood glucose levels, compared to the raise after sucrose only, in healthy volunteers. The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels will be determined over 2 hours after the consumption.
Diabetes Remission and Hypoabsorptive Bariatric Surgery
Severe ObesityDiabetes Mellitus2 moreBariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI > 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.
AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
Type2DiabetesPregnancy in DiabeticThis study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus
Chronic Kidney DiseasesType2DiabetesWhile data from the National Health and Nutrition Examination Survey (NHANES) estimate that 36.9% of patients with diabetes have CKD, only approximately 10% of patients are aware of their kidney disease. In its 2020 Standards of Medical Care in Diabetes, the ADA recommends that all patients with type II diabetes (T2DM) undergo annual measurement of urine albumin-to-creatinine ratio (UACR). The National Kidney Foundation (NKF) has also proposed an update to the requirements for assessment of adults with diabetes including both an estimated glomerular filtration rate (eGFR) and uACR. The goal of accurately identifying patients with T2DM and CKD is to help providers intervene at an earlier stage of kidney impairment, improve renal outcomes, and reduce associated healthcare costs. Failure to adopt these guideline recommendations has widespread implications, including underestimation of the burden of CKD in the T2DM population, delays in diagnosis of renal impairment, and ultimately, underutilization of therapies that could improve clinical outcomes. This single-center, 400-patient, randomized controlled trial will assess the impact of an EPIC Best Practice Advisory (BPA; alert-based CDS tool) on guideline-directed assessment for CKD using UACR in patients with T2DM who have not had a UACR in the past year.
A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
DiabetesGestational3 moreThis study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.
Corazon de la Familia (Heart of the Family)
Risk Reduction BehaviorDiabetes Mellitus2 moreThe Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.
STOP DIABETES - Knowledge-based Solutions
Type2 DiabetesLife Style3 moreThe aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will carry out a 1-year randomized controlled trial on the effects of among 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes.
Chronotherapy With Low-dose Aspirin for Primary Prevention
Type 2 DiabetesBrief summary: Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should also be used as a primary prevention strategy in men and women with diabetes who are at high cardiovascular risk. On the other hand, there is current evidence on the potential benefits of low-dose ASA therapy in subjects with impaired fasting glucose, including those with metabolic syndrome. Most important, previous laboratory animal and clinical trial research convincingly demonstrates administration time-dependent (with reference to circadian rhythms) effects of ASA. Thus, the effects of ASA upon lipoperoxides, b-adrenergic receptors, and blood pressure (BP) in clinically healthy subjects depend on the circadian timing of ASA administration. The administration-time-dependent influence of ASA on BP was previously demonstrated in a randomized trial on healthy women and other independent double-blind, randomized, placebo-controlled clinical trials conducted, first, on clinically healthy subjects, a second one on normotensive and hypertensive subjects, a third one on pregnant women at high risk for preeclampsia and a fourth one in previously untreated patients with mild hypertension. The findings of these BP studies are consistent; BP-lowering effect of low-dose ASA is achieved when administered at bedtime but not upon awakening. In keeping with the chronopharmacological effects of ASA and the previous findings suggesting that ASA at low dose may exert a potential beneficial effect on BP, endothelium function and cardiovascular function, this prospective, randomized, parallel-arm study will investigate the potential influence of ASA on the primary prevention of cardiovascular, cerebrovascular and renal events in subjects with either impaired fasting glucose (≥ 100 mg/dl) or previous diagnosis of type 2 diabetes mellitus, who will receive low-dose ASA (100 mg/day) at different circadian times (upon awakening or at bedtime) in relation to their rest-activity cycle.