Insulin Detemir Action in Cerebro

NCT00626080 | Completed

• 2 other identifiers: DC2007Det0012007-007255-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.

Conditions

Type 1 Diabetes

Keywords

Insulin; Detemir; Brain; Glucose metabolism

Outcome Measures

Primary Outcomes (2)

• Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET

  After 12 weeks of treatment

• Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET

  After 12 weeks of treatment

Secondary Outcomes (3)

• CSF insulin concentration

  After 12 weeks of treatment

• Activity in brain regions associated with appetite control, as determined by fMRI

  After 12 weeks of treatment

• Weight change

  After 12 weeks of treatment

Interventions

Insulin detemir DRUG

100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Also known as: Insulin Levemir

Insulin NPH DRUG

100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Also known as: Insulin Insulatard

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetic patients;
• Diabetes duration =/\> 1 year;
• HbA1c \~ 7,5%;

You may not qualify if:

• Recent onset of DM;
• BMI \< 18 OR \> 35 kg/m2;
• T2DM;
• History of major heart/renal disease;
• Severe untreated proliferative retinopathy;
• History of recurrent severe hypoglycaemia;
• (History of) brain disorders;
• Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants;
• Current psychiatric disease/treatment;
• (history of) eating disorders;
• History of severe head trauma accompanied by loss of consciousness;
• Any endocrine disease not well controlled for at least 3 months;
• Inability to undergo MRI;
• Visual acuity \< 0.3;
• Known or suspected allergy to trial product or related products

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (4)

• van Golen LW, Veltman DJ, IJzerman RG, Deijen JB, Heijboer AC, Barkhof F, Drent ML, Diamant M. Effects of insulin detemir and NPH insulin on body weight and appetite-regulating brain regions in human type 1 diabetes: a randomized controlled trial. PLoS One. 2014 Apr 16;9(4):e94483. doi: 10.1371/journal.pone.0094483. eCollection 2014.

  PMID: 24739875 DERIVED

• van Golen LW, IJzerman RG, Huisman MC, Hensbergen JF, Hoogma RP, Drent ML, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism in appetite-related brain regions in type 1 diabetic patients after treatment with insulin detemir and NPH insulin: a randomized controlled crossover trial. Diabetes Care. 2013 Dec;36(12):4050-6. doi: 10.2337/dc13-0093. Epub 2013 Oct 15.

  PMID: 24130356 DERIVED

• van Golen LW, Huisman MC, Ijzerman RG, Hoetjes NJ, Schwarte LA, Lammertsma AA, Diamant M. Cerebral blood flow and glucose metabolism measured with positron emission tomography are decreased in human type 1 diabetes. Diabetes. 2013 Aug;62(8):2898-904. doi: 10.2337/db12-1159. Epub 2013 Mar 25.

  PMID: 23530004 DERIVED

• Huisman MC, van Golen LW, Hoetjes NJ, Greuter HN, Schober P, Ijzerman RG, Diamant M, Lammertsma AA. Cerebral blood flow and glucose metabolism in healthy volunteers measured using a high-resolution PET scanner. EJNMMI Res. 2012 Nov 20;2(1):63. doi: 10.1186/2191-219X-2-63.

  PMID: 23168248 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin Detemir; Insulin, Isophane; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Regular, Human; Insulin; Proinsulin

Study Officials

• Michaela Diamant, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

NL (1)