Advertisement

Topics

INSUlin Regimens and VASCular Functions

2014-07-23 21:11:40 | BioPortfolio

Summary

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

Description

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients.

The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function.

Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.

Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes

Intervention

Insulin

Location

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy
France
93140

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:40-0400

Clinical Trials [4763 Associated Clinical Trials listed on BioPortfolio]

U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using nonconcentrated forms of insulin (U100 ...

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of i...

Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable...

Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)

The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, cont...

Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

This trial is conducted in Europe. The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insuli...

PubMed Articles [10609 Associated PubMed Articles listed on BioPortfolio]

Prevalence of Diagnosed Diabetes in Adults by Diabetes Type - United States, 2016.

Currently 23 million U.S. adults have been diagnosed with diabetes (1). The two most common forms of diabetes are type 1 and type 2. Type 1 diabetes results from the autoimmune destruction of the panc...

Who's distressed? A comparison of diabetes-related distress by type of diabetes and medication.

We hypothesized that diabetes-related distress would vary by type of diabetes and medication regimen [Type 1 diabetes (T1DM), Type 2 diabetes with insulin use (T2DM-i), Type 2 diabetes without insulin...

Efficacy and Safety of MYL-1501D Versus Insulin Glargine in Patients With Type 1 Diabetes After 52 Weeks: Results of the Phase 3 INSTRIDE 1 Study.

Insulin glargine, a long-acting human insulin analogue, allows for once-daily basal use in patients with type 1 diabetes mellitus (T1DM). MYL-1501D is a proposed insulin glargine biosimilar.

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.

SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult pat...

Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): a 52-week, randomized, treat-to-target, phase 3 trial.

Compare safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D).

Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

Diabetes mellitus induced by PREGNANCY but resolved at the end of pregnancy. It does not include previously diagnosed diabetics who become pregnant (PREGNANCY IN DIABETICS). Gestational diabetes usually develops in late pregnancy when insulin antagonistic hormones peaks leading to INSULIN RESISTANCE; GLUCOSE INTOLERANCE; and HYPERGLYCEMIA.

More From BioPortfolio on "INSUlin Regimens and VASCular Functions"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...


Searches Linking to this Trial