Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes
InsomniaDiabetes1 moreThe aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.
Effect of Dairy Products on Insulin Resistance
Insulin SensitivityGlucose Intolerance1 moreThe objective of the study is to determine the effect of dairy consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of reduced-fat dairy. Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet in a manner that prevents changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.
CPAP Withdrawal and Glucose Metabolism in OSA With Pre-diabetes
Obstructive Sleep ApneaPre-diabetesThe purpose of the current study is to investigate whether temporary, 2-week, CPAP withdrawal will adversely impact glucose metabolism
2-A-Day Study: Twice a Day Meals Study.
PreDiabetesCaloric restriction increases lifespan and/or healthspan across multiple species. However implementation of long-term CR in humans is problematic and unacceptable to many individuals. As a result, intermittent fasting models have been developed to improve adherence. Such models have been shown to improve blood pressure, insulin sensitivity, decrease hepatic fat content and body weight. Investigators established an isocaloric twice-a-day (ITAD) feeding plan in mice, wherein test mice were acclimatized to consume over two hour periods (8-10am and 5-7pm), the same amount of food as ad-libitum mice. This intervention prevented obesity and age-associated type 2 diabetes via system-wide activation of autophagy. The investigators will perform further studies of the same feeding model in humans in a randomized crossover design. The objective is to test the hypothesis that restricting eating periods to twice a day (TAD), when compared to isocaloric ad lib meal timing (ALMT), will have beneficial effects on glucose metabolism, body composition, energy expenditure and autophagy in human subjects at risk for diabetes
Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular...
PreDiabetesOne in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted feeding; TRF) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRF also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRF can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRF depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRF' (eat between ~8 am-3 pm), (2) 'Mid-day TRF' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 10 weeks. All food will be provided and matched between groups.
Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
PreDiabetesThe study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
Impaired Glucose ToleranceOverweight2 moreThis is a prospective, multicenter, parallel-group, participants- and assessors-blinded randomized trial aiming to evaluate the effectiveness and safety of acupuncture in improving glucose metabolism for overweight/obese Participants with IGT, in comparison with sham acupuncture.
Double Blinded, Randomized, Placebo-controlled Parallel Investigation Into the Effects of Supplementing...
Pre-diabetesType 2 diabetes mellitus (T2DM) is a major non-communicable disease and one of the world's fastest growing health problems. According to a 2019 report, about 463 million adults worldwide currently have diabetes and future projections indicate the number of diabetic patients will reach 700 million by 2045.1 T2DM is associated with significant morbidity, including increased risk of cardiovascular diseases (CVD) and stroke, hypertension, retinopathy and blindness, renal failure, and leg amputation. These place an enormous burden on individuals, society and the healthcare system.2 T2DM is a non-reversible but preventable condition with overweight and obesity being major risk factors. The onset of T2DM is gradual, with most individuals progressing from normoglycaemia through a pre-diabetic state. People with pre-diabetes, defined as having impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or impaired glycated haemoglobin (HbA1c),2 are at increased risk of developing T2DM and its associated complications, such as CVD and retinopathy, which can develop even in the absence of progression to overt T2DM.3-5 Pre-diabetes is a prevalent and potentially reversible condition that provides an important window of opportunity for healthcare providers to implement interventions that can delay or prevent T2DM and its complications. A substantial body of literature has provided evidence for the role of gut microbiota in metabolic diseases including type 2 diabetes.6 Indeed, there is evidence for the effects of microbiota on glucose metabolism in both preclinical animal models of T2D and in healthy animals, by means of increasing the number of inflammatory mediators, chronic inflammation, insulin resistance and increased energy intake. Among the commonly reported findings, Bifidobacterium spp appears to be the most consistently supported by the literature genus containing microbes potentially protective against T2DM. Indeed, nearly all papers report a negative association between this genus and T2DM;7-14 while only one paper reported opposite results.15 In view of the correlation between gut microbiota, more specifically Bifidobacterium spp., and diabetes, the Bifidobacterium population and their metabolic action can be taken as an important target for interventions to prevent and/or delay the development of T2DM.
Effect of NNS on Metformin/GDF15, Pilot
ObesityAdolescent1 moreMetformin use for diabetes has the benefit of causing weight loss in some. The investigators in a preclinical trial, demonstrated that mice consuming non-nutritive sweetened (NNS) drinks had worse glucose improvements and weight loss than mice consuming sugar drinks or water. This study will conduct a pilot to determine if this translates into pediatric clinical practice. The hypothesis is that NNS drinks impair metformin-induced satiation, weight loss, and glucose tolerance.
Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β
HyperinsulinemiaPreDiabetesThe goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.