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Abnormal Glucose Metabolism clinical trials

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NCT ID: NCT02457897 Recruiting - Diabetes Mellitus Clinical Trials

Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations

Start date: April 15, 2015
Phase: Phase 2
Study type: Interventional

Background: - Insulin receptor mutation causes high blood sugars and sometimes diabetes complications. Researchers want to see if thyroid hormone helps. Objectives: - To see if thyroid hormone treatment changes how the body handles sugar in people with insulin receptor mutation and improves blood sugar in people with diabetes. Eligibility: - People ages 12 65 with an insulin receptor mutation. Design: - Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15 days they will take a thyroid hormone pill 3 times a day. Participants will have: - Blood tests. - Heart rate and skin temperature monitored. - All their food provided. - Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit still. - Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a non-radioactive tracer. Participants will also drink water with a tracer. The other tube will collect blood. - A sweet drink. Participants may have finger stick blood sugar tests. - Glucose-monitoring device inserted into body fat for two 24-hour periods. - Adults may have samples of fat and muscle taken. - Heart ultrasound. - PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small amount of radioactive substance will be injected. - DEXA scan of body fat and bone density. - Participants with poorly controlled diabetes will then take thyroid hormone at home for 6 months. They will have blood drawn and sent to the study team monthly. - After about 3 months, they will have an overnight visit. After 6 months, they will have a 4-day visit.

NCT ID: NCT01007266 Completed - Obesity Clinical Trials

Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

Start date: October 9, 2009
Phase: Phase 2
Study type: Interventional

Background: - Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in minority populations. Few drug treatments are approved for T2DM in adolescents, and behavioral and lifestyle factors may contribute to their difficulties in following strict treatment regimens. - It is unknown whether a minimally invasive patient partner ( buddy ) program, which has been developed to help improve diabetes control and quality of life, will be successful in a population of pediatric patients with T2DM. Objectives: - To evaluate the effect of a minimally invasive intervention (being assigned a patient partner, or buddy ) on blood sugar levels in adolescents with T2DM. - To assess changes between groups in body weight, number of home glucose monitor checks, compliance with medications, adherence to visit schedule, and psychological well-being. Eligibility: - Adolescents and young adults between 12 and 20 years of age who have been diagnosed with type 2 diabetes and whose blood glucose control needs improvement. Design: - Participants will be divided by chance into two groups: in one group, participants will have a buddy and receive standard care; while in the other group, participants will receive standard care alone. - The buddy is not a health care professional and is not authorized to provide any medical advice. - Participants will be followed in the study for a total of 6 months. All study participants will receive standard treatment for T2DM. - All patients will be asked to fill out a screening questionnaire (on paper or online) at the beginning of the study and a quality of life and eating behaviors questionnaire at the beginning and at the end of the study. These forms will include questions on medical history, emotions, well-being, and eating habits. - Participants in both groups will have one diabetes clinic visit at the NIH Clinical Center or at Children s National Medical Center (CNMC) at the beginning of the study and two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include a physical examination, detailed medical history, and laboratory testing which is part of routine care for diabetes. - Participants assigned to the buddy group will receive phone or online messages from the buddy once a week and will meet with the buddy once a month for less than 1 hour. The purpose of the in-person visit is to get to know each other better outside the usual hospital or clinic environment. The visits should take place at home, but may also take place elsewhere, for example, at schools, cafes, or libraries chosen by both the participant and the buddy. These face-to-face meetings may also take place at NIH or at CNMC if this is more convenient.