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Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212290
First Posted: September 21, 2005
Last Update Posted: February 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 20, 2005
September 21, 2005
February 15, 2010
November 2002
Not Provided
  • Verbal memory (main study)
  • Selective attention (main study)
  • Plasma beta-amyloid levels (main study)
  • Cerebral glucose metabolism (sub-study)
  • Inflammatory markers in spinal fluid (sub-study)
  • Beta-amyloid in spinal fluid (sub-study)
Same as current
Complete list of historical versions of study NCT00212290 on ClinicalTrials.gov Archive Site
  • Psychomotor speed
  • Verbal fluency
  • Blood levels of insulin, insulin degrading enzyme, cortisol and inflammatory markers
Same as current
Not Provided
Not Provided
 
Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes
Not Provided
The purpose of this study is to examine the effects of treating insulin resistance on memory and attention, brain glucose utilization, and proteins in spinal fluid.
Insulin resistant conditions such as impaired glucose tolerance, type 2 diabetes mellitus, and hyperinsulinemia have been associated with an increased risk for memory decline and for Alzheimer's disease. The main study will determine whether treatment with pioglitazone or nateglinide will improve verbal memory and selective attention for older adults with impaired glucose tolerance or mild type 2 diabetes. The main study will also characterize changes in blood concentrations of insulin, inflammatory markers, and the beta-amyloid peptides that are related to Alzheimer's disease. In one sub-study, participants will undergo brain positron emission tomography (PET) imaging before and after 16 weeks of treatment with pioglitazone, nateglinide, or placebo. The purpose of this sub-study is to determine the effects of treatment on brain glucose utilization. In a second sub-study, participants will undergo a lumbar puncture procedure before and after treatment. The purpose of this sub-study is to determine the effects of treatment on spinal fluid concentrations of insulin, inflammatory markers, and beta-amyloid peptides. Together these main and sub-studies should characterize the effects of insulin resistance on cognition and suggest a mechanism by which insulin resistant conditions increase risk for memory decline and for Alzheimer's disease.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Insulin Resistance
  • Type 2 Diabetes Mellitus
  • Drug: pioglitazone
  • Drug: nateglinide
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2006
Not Provided

Inclusion Criteria:

  • Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar regulation
  • Stable weight and activity level

Exclusion Criteria:

  • Medications for diabetes
  • Dementia
  • Medications with known effects on memory
  • Serious neurologic disease or head trauma
  • Serious systemic illness (e.g., renal failure or uncontrolled hypertension)
  • Serious psychiatric illness (e.g., schizophrenia or bipolar disorder)
  • Allergy to pioglitazone or nateglinide
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00212290
DK61606 (completed)
Not Provided
Not Provided
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Suzanne Craft, PhD VA Puget Sound Health Care System, University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP