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The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism (Centrin)

This study is currently recruiting participants.
Verified November 2011 by German Diabetes Center
Sponsor:
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01479075
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

-Insulin has a direct effect on the energy metabolism of the brain under basal conditions and has an effect on the hepatic glucose production, lipid metabolism and the secretion of various hormone

The purpose of this study is to determine whether central insulin influences the human peripheral insulin sensitivity of liver and muscle


Condition Intervention Phase
Diabetes
 Drug: central insulin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of insulin sensitivity with gold standard methods


Secondary Outcome Measures:
  • Energy metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Energy metabolism is assessed from gold standard methods


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin in patients
central insulin is applied to diabetic patients at baseline and during hyperinsulinemic clamps
 Drug: central insulin
4x 40mU intranasal insulin
Other Name: intranasal insulin
Experimental: insulin in study participants
central insulin is applied to healthy patients at baseline and during hyperinsulinemic clamps
 Drug: central insulin
4x 40mU intranasal insulin
Other Name: intranasal insulin
Experimental: placebo in patients Drug: Placebo
Experimental: placebo in study participants Drug: Placebo

Detailed Description:

-Insulin has a direct effect on the energy metabolism of the brain under basal conditions and has an effect on the hepatic glucose production, lipid metabolism in the mouse model The purpose of this study is to determine whether central insulin influences the human peripheral insulin sensitivity of liver and muscle and energy metabolism

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 30 and ≤ 70 years
  • balanced gender ratio (50: 50)
  • BMI 20-25 kg/m² (normal weight subjects)
  • BMI 25-35 kg/m² (obese subjects)

Exclusion Criteria:

  • acute illness within the last 2 weeks before the examination
  • autoimmune diseases and disorders immune- compromised (leukocytes <5000/μl)
  • renal insufficiency (creatinine> 1.5 mg / dl)
  • heart disease, condition after heart attack
  • anemia (Hb <12 g / l, controls at each examination), blood donation within 4 weeks before the examination
  • participation in another study within 2 months before the examination
  • wear a metal or magnetic objects on or in the body
  • claustrophobia
  • use of immunomodulatory drugs (cortisol, antihistamines, aspirin)
  • thyroid disease
  • taking glitazones and insulin therapy
  • pregnancy, lactation, menstruation
  • cigarette smoking, use of alcohol or drugs, psychiatric disorders
  • risk for / or manifest AIDS (HIV) or hepatitis B or C
  • liver disease is not attributed to the existence of a non-alcoholic steatosis
  • night shift work or circumstances, which do not allow the normal day-night rhythm
  • bleeding disorders or disorders in wound healing
  • hypersensitivity to local anesthetics
  • malignant cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479075

Contacts
Contact: Michael Roden, MD, Prof 0211/33 82201 mroden@ddz.uni-duesseldorf.de
Contact: Julia Szendrödi, MD, PhD 0211/33 82203 jszend@ddz.uni-duesseldorf.de

Locations
Germany
German Diabetic Center Recruiting
Düsseldorf, Nordrhein- Westfalen, Germany, 40225
Contact: Michael Roden, Prof, MD     0211/33 82201     michael.roden@ddz.uni-duesseldorf.de    
Contact: Julia Szendrödi, MD, PhD     0211/33 82203     julia.szendroedi@ddz.uni-duesseldorf.de    
Principal Investigator: Julia Szendrödi, MD, PhD            
Sponsors and Collaborators
German Diabetes Center
Investigators
Study Director: Michael Roden, MD, Prof Germyn Diabetic Center
Principal Investigator: Julia Szendrödi, MD, PhD German Diabetes Center
  More Information

No publications provided

Responsible Party: julia szendrödi, Dr PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT01479075     History of Changes
Other Study ID Numbers: Centrin
Study First Received: November 22, 2011
Last Updated: November 23, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
central insulin
insulin resistance
energy metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013