Insulin ResistancePhase 4NCT00212290
Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes
A Phase 4 study testing pioglitazone and nateglinide in people with Insulin Resistance and Type 2 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes Mellitus
- What is being tested?
- pioglitazone and nateglinide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2002to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar regulation
- Stable weight and activity level
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Puget Sound Health Care System (Seattle Campus)
Seattle, Washington, 98108
VA Puget Sound Health Care System (American Lake Campus)
Tacoma, Washington, 98493
About this study
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.
Read the detailed description
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.
- Conditions
- Insulin Resistance, Type 2 Diabetes Mellitus
- Being tested
- pioglitazone, nateglinide, placebo
- Keywords
- impaired glucose tolerance
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
nateglinideDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Secondary outcomes (3)
Psychomotor speed
Verbal fluency
Blood levels of insulin, insulin degrading enzyme, cortisol and inflammatory markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Suzanne Craft, PhD, Principal investigator, VA Puget Sound Health Care System, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212290
- Sponsor's protocol ID
- DK61606 (completed)
- Status last verified
- Feb 2010
- First submitted
- 20 Sep 2005
- Last updated
- 15 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00212290
- Acronym / sponsor ID
- DK61606 (completed)
- Conditions
- Insulin Resistance, Type 2 Diabetes Mellitus
- Keywords
- impaired glucose tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Nov 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar regulation
- Stable weight and activity level
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone | Drug | – |
| nateglinide | Drug | – |
| placebo | Drug | – |
Primary outcome
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)
3 secondary outcomes
Psychomotor speed
Verbal fluency
Blood levels of insulin, insulin degrading enzyme, cortisol and inflammatory markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
Related trials for Insulin Resistance
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Craft, PhD principal investigator
VA Puget Sound Health Care System, University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone and nateglinide in people with Insulin Resistance and Type 2 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal memory (main study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2010.