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Insulin Resistance clinical trials

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NCT ID: NCT05048108 Active, not recruiting - Breast Cancer Clinical Trials

Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors

RACIRO-3
Start date: January 18, 2022
Phase:
Study type: Observational

Majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and Type 2 Diabetes Mellitus (T2DM). Women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. Additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. Many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. Omega-3 polyunsaturated fatty acids (PUFAs) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. The purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 PUFAs with insulin resistance and cognitive function in obese breast cancer survivors. Due to the global pandemic caused by the coronavirus disease of 2019 (COVID-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. The study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. Participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. Participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. Upon receipt of blood samples and completion of all study questionnaires, participation will be complete.

NCT ID: NCT05023993 Active, not recruiting - Prediabetes Clinical Trials

The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

NCT ID: NCT04992299 Active, not recruiting - Obesity Clinical Trials

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT.

NCT ID: NCT04950283 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

MR-based Characterization of Bone Marrow in Its Relevance to Skeletal Disease in Patients With Diabetes

Start date: July 7, 2021
Phase:
Study type: Observational

For a long time, no direct connection was seen between the two common diseases diabetes mellitus and osteoporosis. However, as more and more younger people are affected by obesity, develop type 2 diabetes mellitus and suffer osteoporotic fractures, the question of a connection between these clinical pictures has now arisen. Modern magnetic resonance imaging and spectroscopy techniques allow detailed and non-invasive characterization of bone marrow in different body regions. Low body weight (BMI<20kg/m²) has been shown to be associated with decreased bone density, while obesity has long been associated with high cortical bone mass - the idea of bone health. It has now been proven that obesity also has a negative effect on bone structure. Here, it is not only BMI that is crucial, but also the localization of fat tissue in the body. Visceral fat has a directly damaging effect on bone microarchitecture through dysregulated production and release of cytokines and adipokines. Thus, it has been shown that both type 1 and type 2 diabetic patients have a decreased rate of bone remodeling and very obese patients with type 2 diabetes have an increased risk of fracture. It must be concluded that body weight, or BMI, cannot be the sole measure for estimating bone health. Thus, type 2 diabetes shows reduced bone remodeling with normal or slightly increased bone density, but inferior stability. This means that type 2 diabetes is associated with an increased risk of osteoporotic fracture, even when bone density measurements are unremarkable. Loss of trabecular bone structure in red (hematopoietic) bone marrow is also characterized by increasing infiltration of the bone marrow space with fat cells (bone marrow adipose tissue). In contrast, the yellow bone marrow, which is mainly present in the diaphysis of tabular bones, has particularly large amounts of fat incorporated into the reticulum cells. For a long time, only the role of "placeholder" was attributed to these fat cells, but it has been shown that they interact with other cells via the production of autocrine, paracrine and endocrine hormones and cytokines, or adipokines, and are thus related to the metabolic state of the entire body. A basic assumption here is that the amount of unsaturated fatty acids in the adipose bone marrow is an important and functional marker for different types of adipocytes. It has been shown that 3 individuals with poorer insulin sensitivity have more unsaturated fatty acids in yellow bone marrow. Thus, the concept of different types of adipocytes in the bone marrow, with their inherent different fatty acid composition could serve to reconcile the at first glance counterintuitive physiological regulation of bone marrow fat and its response to metabolic perturbations. In order to show whether and how the composition of the yellow (unsaturated fatty acids) and red (bone marrow adipose tissue) bone marrow differs in healthy individuals, individuals with impaired insulin sensitivity in different age groups and patients with type 2 diabetes, and whether this can be used to detect early changes in the bone matrix with regard to bone density, the proportion of bone marrow adipose tissue in the red bone marrow at different locations in the skeleton will be quantified by means of chemical-shift-selective MRI sequences as well as the composition of bone marrow fat in the yellow bone marrow with regard to the proportions of monounsaturated and polyunsaturated fatty acids by means of volume-selective MRS. A total of 96 healthy volunteers (48 each male and female) aged 25 to 75 years and with body mass index between 18.5 and 35 kg/m² will be included. In addition, 24 patients (12female/12male) with type 2 diabetes will be recruited. After magnetic resonance examination, anthropometric and metabolic characterization (oral glucose tolerance test) will take place.

NCT ID: NCT04722354 Active, not recruiting - Pre Diabetes Clinical Trials

Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

ABA
Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.

NCT ID: NCT04636489 Active, not recruiting - Hyperglycemia Clinical Trials

Effect of Prebiotics on Blood Glucose Management

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.

NCT ID: NCT04528693 Active, not recruiting - Insulin Resistance Clinical Trials

The Effect of 12-week Circuit Training on Insulin Sensitivity and Endothelial Function in Women With Insulin Resistance

Start date: August 17, 2020
Phase: N/A
Study type: Interventional

During the last 10 years many studies concerning the impact of physical training on whole-body insulin sensitivity have been published, but there is a lack of an extended investigation on the potential clinical benefits of novel circuit training-based on strength and endurance exercises-relating to the optimization of insulin sensitivity and vascular endothelial function. It is of interest to precisely determine the physiological and biochemical effects of circuit training. An important aspect of the planned research will be the analysis of the effects of physical training on the released during muscle contraction myokines capable of modulating various metabolic processes. We hypothesized that in studied participants 12 weeks of the novel form of training would result in improving insulin sensitivity and vascular endothelial function mainly via myokines released by contracting skeletal muscles. The following questions will be asked: (1) whether the 12-week circuit training (combined strength and endurance exercises) performed by women with insulin resistance, improves insulin sensitivity, carbohydrate and lipid metabolism and promotes the efficiency of endothelial defense mechanisms? (2) whether the 12-week circuit training (combined of strength and endurance exercises) changes the concentrations of transcription factors regulating lipid and carbohydrate metabolism or the synthesis and/or secretion of myokines and adipokines in women with insulin resistance? (3) whether the 12-week strength training, interspersed with bouts of endurance exercise has a positive effect on cytokine profile? (4) whether there is a relationship between changes in body composition, HOMA-IR, and the level of myokines caused by physical training? (5) whether the 12-week circuit training reduces low back pain symptoms, plantar stifness and improve functioning of the patient in everyday life? A group of 80 women, aged 25 to 45 years, with diagnosed insulin resistance will participate in the planned study. Participants will be enrolled in the research program based on medical qualification. Before the intervention all women will have venous blood collected to determine fasting glucose, hemoglobin glycosylated (HbA1C) and insulin levels and insulin resistance by the homeostasis model assessment of insulin resistance (HOMA-IR) will be calculated. The inclusion criteria will be as follows: (1) women, age: 25-45 years, menstruating, (2) BMI 18,5-29,9 kg/m2, (3) insulin resistance based on HOMA-IR (cut-off point 2.5), (4) HbA1C ≤ 6.5%, (5) not contraindicated to physical activity. Participants meeting the inclusion criteria will be randomly divided into two groups. The first group of women will undergo circuit training, consisting of exercises performed on 7 machines arranged in a circuit. Thanks to the use of adequate software the machines will automatically adjust their parameters, such as seat height or resistance to the exercising person, and the training progress will be individually monitored. The planned training will last for 3 months, during which the patients will exercise 3 times a week for 30 minutes (2 circuits will be done during each session). The planned duration of the training session will be controlled (one minute for strength exercises, four minutes for endurance exercises and a 30-second break between each exercise). In the training group, one-repetition maximum exercise test (1RM) will be performed to determine the appropriate training load and later after the program to verify the increase in muscle strength. The range of maximum heart rate (HRmax) will also be determined in all exercising women. The second group of women, who will be asked to maintain their current level of physical activity and their diet for a period of 3 months will serve as a control group. Before and after the training program in all participants of the study pulse wave velocity, anthropometric parameters and body composition will be assessed. Concurrently venous blood will be taken to determine biochemical indicators related to carbohydrate and lipid metabolism, insulin resistance, vascular endothelium function, inflammation and adipocytokines and myokines. In both groups of women, the questioners concerning dietary intake and the level of daily physical activity will be administered. Results will be subjected to analysis involving descriptive, and advanced statistic method among them analysis of correlations, regression, variance and cluster analysis. All calculations and statistics will be performed using TIBCO Statistica 13.3 software (TIBCO).

NCT ID: NCT04375969 Active, not recruiting - Overweight Clinical Trials

Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Therapeutic effectiveness of coldness in relieving pain and reducing inflammation has been known for many years now. Over that time, various coldness therapies have gained in popularity, including winter swimming, snow baths or whole body cryostimulation (WBC) . Recent researches have shown positive effects of WBC on metabolic profile, low-to-moderate chronic inflammation and related diseases (e.g., obesity). WBC could be, thus, intended as an adjuvant method in the treatment of dysmetabolic conditions, such as overweight or obesity. WBC is a cheap easily accessible practice, with a few well-defined contraindications and limited non severe possible adverse events, if performed in specialized centres. At the same time, in sport science appears data, which indicated on inhibition of adaptive changes induced by regular training. The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 20 consecutive sessions of either WBC, high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight and obese subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.

NCT ID: NCT04341571 Active, not recruiting - PreDiabetes Clinical Trials

Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.

Start date: October 24, 2019
Phase: Phase 2
Study type: Interventional

Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment. The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.

NCT ID: NCT04300049 Active, not recruiting - Insulin Sensitivity Clinical Trials

Effect of Physiologic Hyperglucogonemia on Adipocyte Metabolism

Glucagon
Start date: February 5, 2018
Phase: Early Phase 1
Study type: Interventional

Purpose/Objectives: To investigate the effect of hyperglucagonemia on insulin action, particularly on adipose tissue. Research Design/Plan: Normal glucose tolerant subjects will be studied. Study subjects will receive a continuous glucagon infusion for 12 hours. Following glucagon infusion, subjects will receive prime-continuous tracer infusions for additional 4 hours to measure adipocyte metabolism. Within 6-8 weeks, subjects will return for a repeat study with normal saline as a control group. Methods: All subjects will have an oral glucose tolerance test prior to participation to confirm they are normal glucose tolerant. Subjects will be admitted to the CRC at 4 PM and will receive a continuous glucagon for 12 hours. At 6 AM on the following morning, subjects will receive prime-continuous tracer infusions of the following for 4 hours (14C-glycerol, 3-3H glucose, and D2O). At 10 AM continuous indirect calorimetry will be performed to determine rates of energy expenditure and glucose/lipid oxidation for 40 minutes. At 6 AM a surgical biopsy of abdominal adipose tissue will be performed for measurement of adipocyte metabolism. At 8 AM, the study team will infuse insulin/glucose to test for insulin sensitivity. Clinical Relevance: The results of this study will help the study team to further understand the pathophysiology of metabolic disturbances that is induced by hyperglucagonemia in type 2 diabetes patients.