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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00340132 Completed - Obesity Clinical Trials

Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians

Start date: January 1, 1983
Phase:
Study type: Observational

Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion. <TAB> Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes. ...

NCT ID: NCT00340093 Completed - Diabetes Clinical Trials

Diabetes Management Personal Trainer

Start date: August 23, 2002
Phase: Phase 1
Study type: Interventional

This 1-year study will test the feasibility and effectiveness of a diabetes personal trainer in helping youth with diabetes manage their treatment. It will examine how families with a diabetic child handle the responsibilities of managing diabetes and deal with the changes that come with managing the illness as the child grows up. Children between 11 and 16 years of age receiving treatment for diabetes type 1 at Johns Hopkins University Medical Center may be eligible for this study. The children must have been diagnosed with diabetes at least 1 year before entering the study and must require insulin treatment. One parent of each child will also participate. On entering the study, each child and parent will be interviewed about various topics having to do with taking care of diabetes. After the interview, the children will be randomly assigned to one of two groups: Group 1 will receive education information about diabetes management; Group 2 will be enrolled in a program in which they meet with a diabetes personal trainer 6 to 7 times over 2 months for individualized instruction in planning and evaluating their diabetes care activities. They will also keep in contact with their trainer by telephone. Children in Group 2 will be given a hand-held personal computer device in which they will keep a record of all diabetes-related activities for 3 days, including insulin shots, meals and snacks. In addition, they will wear an accelerometer, a small device that keeps track of the amount of movement they make. At the end of each of the 3 days, the child will complete a 20- to 30-minute telephone interview reviewing the day. They will have a tape-recorded interview about their experiences in taking care of diabetes. Their meetings with the personal trainer also may be taped. Children in both groups will continue to see the doctor at the clinic as they normally would. At 2 and 6 months after starting the study, children in both groups will complete a telephone interview about diabetes management. At 12 months they will complete an in-person interview.

NCT ID: NCT00339885 Completed - Diabetes Clinical Trials

Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus

Start date: June 1, 1996
Phase:
Study type: Observational

The aim of the project is to positionally clone susceptibility genes for NIDDM. Patients will be ascertained in Finland from previous health surveys and hospital discharge records. Approximately 400 affected sib pairs will be collected. Families will be chosen who have, at most, one parent with NIDDM no history of IDDM. A clinical examination will be undertaken on family members and blood drawn for DNA isolation. Covariates such as body weight, blood pressure, lipid levels and urinary albumin will also be measured. The unaffected spouse and children of a subset of probands will be invited to undergo a frequently-sampled intravenous glucose tolerance test (FSIGT) to measure parameters of pancreatic function and peripheral insulin resistance (IR). A number of unrelated elderly non-diabetic subjects will also be identified to conduct a population-based association analysis. The FSIGT analysis will be performed in Los Angeles. The DNA will be shipped to Bethesda where a total genomic scan will be performed using semi-automated fluorescence-based genotyping technology. Data from Bethesda, Los Angeles and Finland will be sent to Ann Arbor where parametric and non-parametric methods will be used to analyse both discrete traits such as NIDDM and intermediate traits like IR....

NCT ID: NCT00339833 Completed - Diabetes Clinical Trials

The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers

Start date: March 2003
Phase: Phase 4
Study type: Interventional

This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In diabetes, blood sugar is higher than normal and can result in serious medical problems, such as blindness and kidney failure. People with subclinical inflammation-inflammation that does not produce symptoms, such as fever, pain, or skin redness-are at increased risk for diabetes. Although the reasons for this are not completely understood, it is known that subclinical inflammation exacerbates insulin resistance, which is a cause of diabetes. Insulin is a hormone that helps control blood sugar, and when it does not work properly, the condition is known as insulin resistance. Normal, healthy volunteers between 18 and 45 years old with a body mass index of at least 30 kg/m2 and who have subclinical inflammation (determined by blood tests) may be eligible for this study. Candidates must be non-smokers and must not have an alcohol or drug problem. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Participants will maintain a standard diet and undergo tests and procedures during a 14-day inpatient stay at the Phoenix Indian Medical Center.

NCT ID: NCT00339781 Completed - Diabetes Clinical Trials

Predictive and Protective Factors in the Cause of Diabetes - A Study in Twins

Start date: February 2005
Phase: N/A
Study type: Observational

This study, conducted at St. Bartholomew's Hospital, London, England, will determine whether cells passed from mother to offspring during pregnancy increase or decrease the child's risk of developing type 1 diabetes. Previous research has shown that certain cells that can be passed from mothers to their children during pregnancy may affect the child's chance of developing other autoimmune diseases. The cells from the mother may persist in the child's blood for years after birth and stimulate the child's immune system in such a way that may either increase or decrease the chance of the child developing diabetes. This study will determine whether these cells are present in identical twins, where only one of the twins has type 1 diabetes. Participants in the British Diabetic Twins Study in England may be eligible to participate. Of each twin pair in the study, one must have type 1 diabetes and the other must be free of the disease. The twins' mother must be alive and willing to provide a blood sample. For female twins only, their children must be alive and willing to provide either a blood or a buccal cell sample (cheek swab). Participants undergo the following procedures: - Both twins in each twin pair provide a blood sample collected on a single occasion. - The mother of each twin pair provides a blood sample collected on a single occasion. - Children of female twins provide a single sample from either the mouth or blood. For children younger than 12 years of age, a cell sample is collected from the inside of the mouth (buccal) using a toothbrush. The child strokes the inside (cheek) of the mouth with the toothbrush ten times on each side, spits this into a collection vial, immediately rinses the mouth with water and adds this rinse to the sample collection vial. Children over 12 years of age may provide either a buccal cell sample or a blood sample.

NCT ID: NCT00339482 Completed - Clinical trials for Diabetes Mellitus, Type 2

Prospective Studies of the Natural History of Diabetes Mellitus and Its Complications in the Gila River Indian Community

Start date: September 3, 1976
Phase:
Study type: Observational

This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease. The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section fo the Branch.

NCT ID: NCT00339313 Completed - Diabetes Clinical Trials

Food Intake and Appetite in the Children of Mothers With Diabetes

Start date: January 12, 2000
Phase: N/A
Study type: Observational

This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed.

NCT ID: NCT00338104 Completed - Diabetes Clinical Trials

Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Start date: July 2004
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design. Note: Lantus insulin is the proprietary name for glargine insulin.

NCT ID: NCT00337298 Completed - Type 1 Diabetes Clinical Trials

The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of two antihypertensive drugs on retinal vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to investigate how the drugs affected vessel diameter, when the subjects were exposed to an increase in blood pressure, induced by isometric muscle contraction and when they were stimulated by flickering light.

NCT ID: NCT00337038 Completed - Hypertension Clinical Trials

Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients

Start date: June 2006
Phase: Phase 0
Study type: Interventional

Our aim is to examine the influence of blood pressure and glycemic control together with N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The study population will include 50 diabetic patient with uncontrolled hypertention that will be recruited from the Hypertension Clinic of Soroka University Medical Center.