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Type 2 Diabetes clinical trials

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NCT ID: NCT02263677 Withdrawn - Type 2 Diabetes Clinical Trials

Evaluation of the DPP-4 Inhibitor Sitagliptin in the Treatment of Non-Alcoholic Fatty Liver Disease Using MRI

Start date: March 2014
Phase: Phase 4
Study type: Interventional

Participants will be persons with type 2 diabetes who are likely to have fatty liver disease. The investigators think that this medication will reduce fatty liver. The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat before and after subjects take a diabetes medication. The investigators will also collect a small amount of blood to measure liver, kidney and hormone functions. This will be done 4 times. Also, at the time of the subject gets their first dose of medication they will have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and body composition). The goal of all of these studies is to determine whether the study drug lowers liver fat.

NCT ID: NCT02198209 Withdrawn - Type 2 Diabetes Clinical Trials

Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation

Start date: December 2019
Phase: Phase 4
Study type: Interventional

Type 2 diabetes is a chronic disease that has reached epidemic proportions. In order to improve our strategies for preventing and treating type 2 diabetes the investigators need to better understand the mechanism of this disease, and the way in which current therapies, such as the drug liraglutide, work to control blood sugar. It is known that liraglutide acts via increasing the secretion of the hormone insulin from the pancreas, hormone that in turn controls blood sugar. However, it is not known whether liraglutide also has actions on the liver. Animal studies have suggested that liraglutide might act by controlling the liver enzyme glucokinase (GCK), an enzyme that increases blood sugar uptake by the liver. This could be a crucial mechanism in which liraglutide controls blood sugar independently of insulin, thus making it beneficial not only in type 2 but also in type 1 diabetes. The effect of liraglutide on GCK activity has not been yet measured in humans. The investigators propose to investigate the acute and chronic effect of liraglutide on GCK by using a simple, widely used procedure (an IntraVenous Glucose Tolerance Test-IVGTT) and a novel approach (mathematical modeling of data obtained from this procedure), to assess GCK activity in people with type 2 diabetes. The investigators will first compare data obtained form 2 IVGTTs (with and without liraglutide) performed 1 week apart (acute effect). The investigators will then give liraglutide to patients for 6 weeks and do another IVGTT to measure GCK activity (chronic effects). Data obtained from this study will be used to further understand the mechanism of liraglutide action and how to better employ our current therapeutic options and develop new strategies for preventing and treating diabetes.

NCT ID: NCT02171351 Withdrawn - Type 2 Diabetes Clinical Trials

Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)

ELECTROSYMP2
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. However, adherence to PA is often poor, due to a lack of motivation or due to disabling complications or comorbidities. Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. The investigators have already shown in a first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up to 50% in the most deconditioned subjects. Discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. The investigators hypothesize the involvement of neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. Muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. The investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by NMES could be involved in the improvement of insulin sensitivity. To address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital NMES session. The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (VC) will also be evaluated. These procedures will also be applied in healthy control subjects.

NCT ID: NCT02122835 Withdrawn - Heart Failure Clinical Trials

Exercise, Heart Failure, and Type 2 Diabetes

Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

NCT ID: NCT01999452 Withdrawn - Type 2 Diabetes Clinical Trials

The Swedish Study on Paleolithic Diet for Type 2 Diabetes

SwePaD
Start date: October 2015
Phase: N/A
Study type: Interventional

Background Paleolithic diet is a modern dietary regimen based on food eaten during the Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits, vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic is avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for Paleolithic diet is based on the lack of type 2 diabetes and associated diseases among hunter-gatherer populations. Our group have previously studied effects of Paleolithic diet in an observational study in humans, an intervention study in animals and two intervention studies in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart disease. Our intervention studies showed significant improvement of glucose tolerance, HbA1c, blood lipids, blood pressure, weight, waist circumference and satiety on Paleolithic diet compared with a Mediterranean-type diet and diabetes diet. Studies by other research groups on healthy individuals found that Paleolithic diet lowered weight, waist circumference, blood pressure, PAI-1, blood lipids and ectopic lipid deposition, and also improved glucose tolerance and insulin sensitivity. Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases in a sufficiently large and well executed study to be included in basis for future dietary recommendations. Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over dietary intervention on 150 patients with type 2 diabetes where the whole study population upon finishing the initial dietary intervention is studied as a cohort for another 5 years. The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6 months on recommended diabetes diet separated by 6 months wash-out period. After the initial 18 month long dietary intervention the study participants are recommended to follow recommended diabetes diet with implementation of optional elements from a Paleolithic diet for the remaining 5 years of the study. The intervention, in the form of diet information, will be given orally and written by the study participant's own diabetes nurse or doctor, based on similarly designed written information on the two diets. The same intervention was successfully used in our pilot study. The study participants will otherwise receive usual treatment. Power calculations show that 126 participants are needed to obtain significant results with 80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with the same intervention but slightly healthier participants than the average patient in Diabetesregistret showed significant results on HbA1C with only 13 participants. Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure, blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity, monofilaments (detection of peripheral neuropathy) and health related quality of life assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as medication will be registered before and after each intervention diet. Data on primary and secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases will be retrieved for up to five years after participants' completion of the dietary intervention from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and the Hospital Discharge Register (Patientregistret) and compared to expected outcome from a statistical model based on the Diabetes register (A new model for 5-year risk of cardiovascular disease Cederholm et al 2011) and/or a matched control group from the Diabetes register. Participants will be recruited nationwide through information to health care personnel in primary health care and hospital diabetes clinics and to patient organisations. Participants' registration, intervention and data gathering will be administered by the participants' own diabetes nurse or doctor via REDCap, a web based tool for secure electronic data capture hosted on secure servers with daily back-up by the Library and IKT department of the medical faculty at Lund University. Dietary evaluation will be made using four day weighed food records on paperforms before and after each intervention diet and 6 months after the last intervention.

NCT ID: NCT01971047 Withdrawn - Type 2 Diabetes Clinical Trials

Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate preoperative period in patients with diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC). In this randomized controlled clinical trial patients with diabetes will be administered corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to determine whether SC humalog results in improved intra and post-operative blood sugar control.The most common current practice at Emory University in the ambulatory surgical setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia. Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.

NCT ID: NCT01954472 Withdrawn - Clinical trials for Cardiovascular Diseases

Enhanced Multicenter Dietary Portfolio Study

EDP8
Start date: n/a
Phase: N/A
Study type: Interventional

"Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.

NCT ID: NCT01930448 Withdrawn - Type 2 Diabetes Clinical Trials

Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Start date: September 2008
Phase: N/A
Study type: Observational

Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

NCT ID: NCT01917669 Withdrawn - Type 2 Diabetes Clinical Trials

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease

Start date: October 2013
Phase: N/A
Study type: Observational

The purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. By doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with Type 2 diabetes can identify and predict patients at greatest risk for later complications.

NCT ID: NCT01820273 Withdrawn - Obesity Clinical Trials

Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

Start date: April 2013
Phase:
Study type: Observational

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.