Topics

IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes

2020-01-21 11:32:40 | BioPortfolio

Summary

A prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2).

Description

The role of the immune system in metabolism has been extensively investigated in pancreatic islets and insulin sensitive tissues. However little attention has been given to a potential role of the innate immune system in the cephalic phase of insulin secretion. In humans, the cephalic phase of insulin secretion appear reduced in obesity and in patients with type 2 diabetes.

In this prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial we aim to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2).

After screening, subjects will be randomized to three crossover visits with a washout period of at least 4 days in-between: A) subcutaneous saline injection 3h before an oral standardized meal, B) subcutaneous injection of 100 mg of the IL-1 receptor antagonist anakinra 3h before an oral standardized meal, C) subcutaneous saline injection 3h before the same standardized meal will be administered through a nasogastric tube. Treatments will be placebo controlled, double blinded for the oral meal and single blinded for the meal application via a nasogastric tube.

Study Design

Conditions

Diabetes Mellitus Type 2 in Obese

Intervention

Anakinra Prefilled Syringe

Location

University Hospital Basel
Basel
Basel BS
Switzerland
4031

Status

Not yet recruiting

Source

University Hospital, Basel, Switzerland

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-21T11:32:40-0500

Clinical Trials [7001 Associated Clinical Trials listed on BioPortfolio]

Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expr...

Effects of Anakinra in Subjects With Autoimmune Inner Ear Disease

A Phase II randomized, placebo controlled study design of anakinra (Kineret) in autoimmune inner ear disease (AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or...

Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

This is a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration an...

Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector

To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector

Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients

the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first clinical results of the...

PubMed Articles [10229 Associated PubMed Articles listed on BioPortfolio]

Pharmacotherapy of Children and Adolescents with Type 2 Diabetes Mellitus.

Increasing obesity and overweight has led to increased prevalence of type 2 diabetes mellitus (T2D) in adolescents and young adults all over the world. Overweight naturally reduces insulin sensitivity...

Educational weight loss interventions in obese and overweight adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

The worldwide prevalence of type 2 diabetes mellitus is increasing, with most individuals with the disease being overweight or obese. Weight loss can reduce disease-related morbidity and mortality, an...

Efficacy and safety of Cinnamon in Type 2 Diabetes Mellitus and Pre-diabetes patients: A Meta-analysis and Meta-regression.

Cinnamon has been used as a dietary component and in the management of diabetes mellitus. This study systematically reviewed and synthesized evidence on the efficacy of cinnamon for the treatment of t...

Differences in Sleep Architecture According to Body Mass Index in Children with Type 1 Diabetes.

Slow wave sleep (SWS), or deep sleep, is thought to be the most restorative stage of sleep and may be of a particular interest in the pathophysiology of obesity. The aim of this study was to investiga...

Correlation between serum leptin level and Body mass index (BMI) in patients with type 2 diabetes Mellitus.

To correlate serum leptin levels in obese and non-obese type 2 diabetic patients and compare them with healthy individuals.

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 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.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

More From BioPortfolio on "IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...


Searches Linking to this Trial