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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00065663 Completed - Diabetes Clinical Trials

Gene Therapy to Improve Wound Healing in Patients With Diabetes

Start date: August 2002
Phase: Phase 1
Study type: Interventional

Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue.

NCT ID: NCT00065650 Completed - Clinical trials for Diabetes Mellitus, Type 2

Pilot Study of Vedic Medicine for Type 2 Diabetes

Start date: July 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.

NCT ID: NCT00065130 Completed - Diabetes Clinical Trials

Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes

Start date: April 2000
Phase: Phase 3
Study type: Interventional

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.

NCT ID: NCT00064714 Completed - Diabetes Mellitus Clinical Trials

Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

Start date: July 2003
Phase: Phase 2
Study type: Interventional

This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.

NCT ID: NCT00063674 Completed - Obesity Clinical Trials

Type 2 Diabetes Primary Prevention for At Risk Girls

Start date: April 2003
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls. The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke. Our Two Approaches: 1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. 2. After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years. Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.

NCT ID: NCT00063583 Completed - Diabetes Mellitus Clinical Trials

Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes

Start date: June 2003
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.

NCT ID: NCT00063128 Completed - Clinical trials for Diabetes Mellitus, Type 1

Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

Start date: April 2003
Phase: Phase 2
Study type: Interventional

This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.

NCT ID: NCT00059254 Completed - Obesity Clinical Trials

Differential Metabolism of Dietary Fatty Acids

Start date: September 2000
Phase: N/A
Study type: Interventional

Differences in how diet fats are converted to energy could explain some of the reported differences in health effects among different classes of dietary fat (e.g. monounsaturated vs. saturated). Recently, this laboratory showed that monounsaturated fats are turned into energy more readily than saturated fats. These results may mean that if one feeds more monounsaturated fatty acids (MUFA) and less saturated fatty acids (SFA) in the diet, body fat might accumulate at a lower rate. This could affect the risk of obesity and Type 2 Diabetes. This project has two principal Specific Aims which will be assessed in healthy young adults who are fed liquid formulas containing either an approximately equal amount of MUFA and SFA (controls) or a much greater amount of MUFA and much less SFA: 1. To determine if a higher intake of MUFA and a reciprocally lower intake of SFA is associated with a higher rate of fat oxidation. We hypothesize that the rate of fat oxidation after eating will be higher in those subjects randomized to the MUFA-enriched diet compared to controls. 2. To measure energy intake required to maintain constant body weight during each diet and to measure fat-free mass and fat mass, before and after each dietary change. We hypothesize that those on the high MUFA diet will need a higher energy intake required to maintain constant body weight.

NCT ID: NCT00057499 Completed - Diabetes Mellitus Clinical Trials

Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics

Start date: March 2003
Phase: Phase 1
Study type: Interventional

Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction. Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.

NCT ID: NCT00057317 Completed - Diabetes Clinical Trials

Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Start date: December 2001
Phase: Phase 2
Study type: Interventional

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.