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Type 1 Diabetes clinical trials

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NCT ID: NCT01265017 Withdrawn - Type 1 Diabetes Clinical Trials

Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This is a randomized, double-masked, placebo-controlled, single-center study to evaluate stimulated C-peptide secretion after exogenous administration of mild immunosuppression and growth-promoting factors to women with preexisting T1DM who had a decline in insulin requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a parallel group design. Participation for individual subjects will consist of an initial Screening Visit, a 2-week baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment discontinuation. Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8 hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).

NCT ID: NCT01178476 Withdrawn - Type 1 Diabetes Clinical Trials

Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

Start date: November 2009
Phase: N/A
Study type: Interventional

Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic control, which in turn leads to increased diabetes related morbidity and mortality. Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with characteristic changes in EEG with a decrease in alpha activity and an increase in delta and theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can be recorded from subcutaneously placed electrodes using an automated mathematical algorithm based on non-linear spectral analysis. Experimental findings hold promises that an alarm, given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by ingestion of carbohydrate. This is the first larger scale trial testing the clinical applicability of a hypoglycaemia-alarm based on real-time analysis of EEG-signals.

NCT ID: NCT01030471 Withdrawn - Type 1 Diabetes Clinical Trials

Supporting Treatment Adherence Needs in Diabetes

STAND
Start date: September 2009
Phase: N/A
Study type: Interventional

There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.

NCT ID: NCT00946426 Withdrawn - Type 1 Diabetes Clinical Trials

Insulin Resistance in Type I Diabetes in Pediatric Care

Start date: July 2009
Phase: N/A
Study type: Observational

24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.

NCT ID: NCT00829062 Withdrawn - Type 1 Diabetes Clinical Trials

Expanding Coverage of Continuous Subcutaneous Insulin Infusion in Pediatric Patients With Diabetes

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of the study is to present evidence based literature and clinical data to the medical directors at Missouri Medicaid to help modify the existing policy regarding insulin pump therapy in pediatric patients with diabetes.

NCT ID: NCT00824395 Withdrawn - Type 2 Diabetes Clinical Trials

The Genetics of Diabetes in Southern California Chinese Americans

Start date: January 2006
Phase:
Study type: Observational

The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.

NCT ID: NCT00643110 Withdrawn - Type 1 Diabetes Clinical Trials

Milk as Treatment for Hypoglycemia

Start date: April 2008
Phase: N/A
Study type: Interventional

Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.

NCT ID: NCT00608816 Withdrawn - Type 1 Diabetes Clinical Trials

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

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

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

NCT ID: NCT00608101 Withdrawn - Type 1 Diabetes Clinical Trials

Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Start date: September 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.

NCT ID: NCT00605774 Withdrawn - Type 1 Diabetes Clinical Trials

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q5

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

When a patient with Type 1 diabetes exercises, he or she is more prone to low blood sugar, or hypoglycemia. It is known that antecedent exercise can blunt defense responses, called counterregulatory responses to subsequent hypoglycemia in Type 1 DM, causing him or her to be vulnerable to another bout of hypoglycemia. Epinephrine is one of the important hormones in the defense of blood glucose during both exercise and hypoglycemia. We will test the hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.