HyperglycemiaNCT02272556
Investigating the Role of the Polyol Pathway in the Central Nervous System
A study testing Brain MRS during hyperglycemic clamp and Analysis of Metabolites in cerebrospinal fluid in people with Hyperglycemia, run by Yale University at 1 site in United States.
Trial summary
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Brain MRS during hyperglycemic clamp and Analysis of Metabolites in cerebrospinal fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 18 May 2022
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI > 30 kg/m^2) OR age-matched lean, healthy control subjects (BMI < 25 kg/m^2)
- Age 18-55
- BMI 18-45 kg/m^2
Who cannot join
- Creatinine > 1.5 mg/dL
- Hgb < 10 mg/dL
- ALT > 2.5 x ULN
- Untreated thyroid disease
- Uncontrolled Hypertension
- Known Neurological Disorders
Show all 14Show fewer
- Untreated Psychiatric Disorders
- Malignancy
- Bleeding Disorders
- Smoking
- Current or recent steroid use in last 3 months
- Illicit drug use
- Pregnancy, actively seeking pregnancy, or breastfeeding
- Inability to enter MRI/MRS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Role of Polyol Pathway in the Central Nervous System
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.
- Conditions
- Hyperglycemia
- Being tested
- Brain MRS during hyperglycemic clamp, Analysis of Metabolites in cerebrospinal fluid
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRS during hyperglycemic clampOther
All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique
Analysis of Metabolites in cerebrospinal fluidOther
All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Type 2 Diabetes | Active comparator | Type 2 DM subjects with HbA1C > 7.5% treated with metformin, sulfonylurea, insulin or combination Receives: Other: Brain MRS during hyperglycemic clamp; Other: Analysis of Metabolites in cerebrospinal fluid |
| Non-Diabetic Obese | Active comparator | Age-matched, non-diabetic obese (BMI > 30 kg/m^3) individuals Receives: Other: Brain MRS during hyperglycemic clamp; Other: Analysis of Metabolites in cerebrospinal fluid |
| Lean, healthy control subjects | Active comparator | Age-matched, lean, healthy control subjects (BMI < 25 kkg/m^3) Receives: Other: Brain MRS during hyperglycemic clamp; Other: Analysis of Metabolites in cerebrospinal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite Measurements by MRS
metabolite levels will be measured by MRS
Measured: 4 hours post hyperglycemia
Secondary outcomes (3)
Hunger Ratings
Hunger will be measured using a visual analog scale
Measured: 4 hours post hyperglycemia
Satiety Ratings
Satiety will be measured using a visual analog scale
Measured: 4 hours post hyperglycemia
Cognitive State
Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment
Measured: 4 hours post hyperglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Robert Sherwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272556
- Sponsor's protocol ID
- 1408014461
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2014
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Polyol Pathway in the Central Nervous System
- ClinicalTrials.gov ID
- NCT02272556
- Acronym / sponsor ID
- 1408014461
- Conditions
- Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Feb 2015
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 23 Oct 2014 (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.
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with Type 2 Diabetes | Active comparator | Other: Brain MRS during hyperglycemic clamp, Other: Analysis of Metabolites in cerebrospinal fluidType 2 DM subjects with HbA1C > 7.5% treated with metformin, sulfonylurea, insulin or combination |
| Non-Diabetic Obese | Active comparator | Other: Brain MRS during hyperglycemic clamp, Other: Analysis of Metabolites in cerebrospinal fluidAge-matched, non-diabetic obese (BMI > 30 kg/m^3) individuals |
| Lean, healthy control subjects | Active comparator | Other: Brain MRS during hyperglycemic clamp, Other: Analysis of Metabolites in cerebrospinal fluidAge-matched, lean, healthy control subjects (BMI < 25 kkg/m^3) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI > 30 kg/m^2) OR age-matched lean, healthy control subjects (BMI < 25 kg/m^2)
- Age 18-55
- BMI 18-45 kg/m^2
Key exclusion criteria (14 listed)
- Creatinine > 1.5 mg/dL
- Hgb < 10 mg/dL
- ALT > 2.5 x ULN
- Untreated thyroid disease
- 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 |
|---|---|---|
| Brain MRS during hyperglycemic clampAll patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique | Other | Lean, healthy control subjects, Non-Diabetic Obese, Subjects with Type 2 Diabetes |
| Analysis of Metabolites in cerebrospinal fluidAll patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid | Other | Lean, healthy control subjects, Non-Diabetic Obese, Subjects with Type 2 Diabetes |
Primary outcome
Metabolite Measurements by MRS
Time frame: 4 hours post hyperglycemia
metabolite levels will be measured by MRS
3 secondary outcomes
Hunger Ratings
Time frame: 4 hours post hyperglycemia
Satiety Ratings
Time frame: 4 hours post hyperglycemia
Cognitive State
Time frame: 4 hours post hyperglycemia
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 18 Aug 2022.
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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.
Robert Sherwin, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRS during hyperglycemic clamp and Analysis of Metabolites in cerebrospinal fluid in people with Hyperglycemia, run by Yale University at 1 site 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 3 inclusion and 14 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Metabolite Measurements by MRS (time frame: 4 hours post hyperglycemia). 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 18 Aug 2022.