68 Clinical Trials for Various Conditions
Bio-fermentation produced Human insulin is available without prescription in the U.S. This study is a physician-initiated trial of a formula enabling transdermal delivery of human insulin.
The objective of the proposed study is to investigate the effect of cinnamon on the postprandial glycemic response to a high glycemic index meal in normal and overweight/obese prediabetic subjects
GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation
The purpose of the present study was to determine the effects of different type of snack consumption on postprandial satiety, glucose, insulin, antioxidant capacity and anxiety in healthy subjects.
This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to other fatty acids.
This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.
The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.
The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).
The primary objective aims are to assess the effects of regular consumption of red raspberries (RRB) with and without fructooligosaccharide (FOS) on the composition of the gut microbiota after 4 week intake and in parallel characterize plasma and urine metabolite profiles examining qualitative and quantitative intervention associated changes.
The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI).
Certain types of rice have more dietary fiber than others. This type of rice is known a "high amylose rice." This study hypothesizes that high-amylose rice, will decrease blood glucose and insulin responses after consumption compared to conventional rice in healthy adults, ages 18-40. Eighteen healthy men and women will participate in this study. This study will determine how high blood glucose and insulin values rise after eating a portion of rice. This study will also evaluate hunger ratings after consuming rice. The results of this study will help researchers better understand how diet can influence diabetes management.
The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise. The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus.
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.
The investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting \>13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Furthermore, the investigators hypothesize that the SIT and SIT+EX groups will have a less favorble insulin response compared to the physically active group after performing the same 1-hour exercise bout (ACTIVE+EX).
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. The investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.
The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.
Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant negative effect on skin blood flow. In addition, improper management of blood sugar is a major risk factor for PU development and it impedes healing. It would appear that hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that target the blood vessels may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the lower extremity were shown to be much lower than healthy individuals. The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic region PU has 2 phases: (1) a 4-week "observation" phase \[if the PU does not heal appropriately (determined by digital photos and software computation), and the subject is found to be insulin resistant then they will progress to the next phase of the study\] and (2) an 8-week "treatment" phase. All participants will continue to receive the standard wound care throughout the observation and treatment phases. If the surface area of the PU does not decrease by more than 30% during the 4-week observation phase, the participant will be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to receive active drug (e.g., pioglitazone) or placebo. The participants will have four study visits in which the following will be acquired: digital image of the wound to monitor wound surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional status (albumin and pre-albumin), a complete blood count with differential, and makers of inflammation. Weekly monitoring of symptoms and participant experiences will be closely monitored.
The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet. The investigators will also study the following: 1. The impact of diet induced weight loss on hormones/adipokine levels 2. The impact of diet induced weight loss on leptin tolerance
This study will examine whether epigallocatechin gallate (EGCG), a major component of green tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as effective in people who are overweight, have high blood pressure or diabetes. This condition is known as insulin resistance. Laboratory studies suggest that green tea or EGCG treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if EGCG improves insulin resistance or insulin's effects on blood flow in people with insulin resistance. Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take EGCG or a placebo ( inactive dummy pill ) in two 4-week treatment phases with a 2-week period of no study medication before each treatment phase. After the first 4-week treatment, patients on placebo are switched to EGCG and those on EGCG are switched to placebo. In addition to treatment, participants undergo the following procedures during the study period: * Screening, including medical history, physical examination and blood and urine tests, and finger-stick blood sugar measurement for patients with diabetes * Complete a dietary and physical activity questionnaire and consult with a dietitian * Blood and urine tests * At-home and clinic blood pressure monitoring * Glucose clamp test to measure how the body responds to insulin. This test is done three times during the study. A needle is placed in a vein in each of the subject's arms, one for sampling blood and the other for infusing insulin, glucose and potassium. Glucose and insulin levels, electrolytes, lipids, fatty acids, cytokines and epicatechin are measured. * Forearm blood flow measurement with microbubbles and ultrasound. Before beginning the glucose clamp test, a test of how well the blood vessels relax is done. A device that measures the size of the artery in the upper arm is placed above the elbow. Blood flow in the muscle of the forearm is measured by ultrasound using a small infusion through a vein of microbubble contrast agent consisting of gas-filled bubbles the size of red blood cells. The contrast agent is infused over a 7- to 9-minute period at the beginning of the glucose clamp test and again 2 hours after the beginning of the test.
Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear. Dr. Philip Cryer has previously reported that, in T1D young adults with a course of the disease of 16+9 years, the absence of endogenous insulin secretion results in increased glucagon secretion after a mixed meal, concluding that endogenous insulin reciprocally regulates the alpha-cell glucagon secretion and also suggesting that glucagon dysregulation may play an important role in post-prandial hyperglycemia in T1D. Interestingly, recent research on human islets have shown that insulin inhibits counter-regulatory glucagon secretion by a paracrine effect mediated by SGLT2-dependent stimulation of somatostatin release. An important gap in our knowledge is whether the timing of prandial insulin doses affects the glucagon response to a hyperglycemic stimulus in patients with T1D who have undetectable C-peptide. Whether appropriately timed exogenous insulin can modify the glucagon response to glucose fluctuations has not been studied. As such, this pilot study aims to characterize the glucagon response to meal-time hyperglycemia and to compare the difference in glucagon secretion when mealtime bolus insulin is given before the meal versus after the meal with the objective of understanding factors that contribute to the peak post-prandial blood glucose and AUC of blood glucose after a mixed meal in this target population.
Many of the beneficial metabolic effects of endurance exercise training are not due to adaptations to weeks, months, or even years of training, but rather much is due to the response to the most recent exercise session(s). Therefore, the investigators contend that lifestyle interventions for obese individuals should be tailored to optimize the metabolic effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke these beneficial responses is not known, and the mechanisms responsible for these improvements are poorly understood. The findings from these studies will: 1) establish the minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next day in obese adults, 2) characterize the underlying metabolic factors responsible for the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program. Findings from these studies will provide valuable information for the development of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise session in obese patients.
This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered subcutaneously.
Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate that most of the excess morbidity from obesity is related to insulin resistance (IR). While total adiposity correlates with insulin resistance, not all obese individuals are IR. When obese IR individuals lose weight in response to caloric restriction, even moderate loss of body fat results in improved insulin sensitivity (IS). With massive weight loss, either dietary or surgical, even the most IR individuals can completely reverse their insulin resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There must be differences in the manner in which adipose cells/tissue respond to caloric excess and weight gain. One potentially unifying hypothesis with regard to obesity-associated insulin resistance is that those individuals who fail to respond to caloric excess/obesity with adequate adipocyte differentiation and expanded subcutaneous fat storage capacity develop increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering localized and systemic inflammation and ultimately insulin resistance in skeletal muscle. Clearly, the best way to examine the human response to obesity is to challenge overweight individuals with the need to store excess triglyceride in adipose tissue. Specific aims are: 1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated with insulin resistance by comparing 1) cell size distribution; 2) gene markers of adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone vs IS individuals subjected to caloric excess. 2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS individuals subjected to caloric excess. 3. Determine whether differences in inflammation and/or innate or adaptive immune response are associated with insulin resistance by comparing differences in resident dendritic cells, macrophages and their activation profiles, changes in T-cell subpopulations, and other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric excess via overfeeding. 4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and insufficient angiogenic response in response to caloric excess.