Hyperglycaemia (Diabetic)Early Phase 1NCT03469492
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
A Early Phase 1 study testing Insulin, exercise and Dietary counseling in people with Hyperglycaemia (Diabetic), run by Yale University at 1 site in United States.
Trial summary
To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperglycaemia (Diabetic)
- What is being tested?
- Insulin, exercise and Dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 20 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 15 Type 2 DM subjects with HbA1C > 7.5%
- 15 Type 1 DM subjects with HbA1C > 7.5%
- Age 18-60
- BMI ≥18 kg/m2
- Weight ≤ 285 pounds
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,
- untreated psychiatric disorders,
- malignancy,
Show all 11Show fewer
- bleeding disorders,
- current or recent steroid use in last 3 months,
- illicit drug use;
- for women: 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 the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study
To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.
Read the detailed description
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.
- Conditions
- Hyperglycaemia (Diabetic)
- Being tested
- Insulin, exercise, Dietary counseling
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.
exerciseBehavioural
Exercise in accordance to the guidelines established by the American Diabetes Association.
Dietary counselingDietary supplement
Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes mellitus | Active comparator | Subjects with type 2 diabetes on insulin. Receives: Drug: Insulin; Behavioral: exercise; Dietary Supplement: Dietary counseling |
| type 1 diabetes mellitus | Active comparator | Subjects with type 1 diabetes on insulin. Receives: Drug: Insulin; Behavioral: exercise; Dietary Supplement: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Levels
HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Gluthathione
baseline MRS scan to measure gluthathione
Measured: 0 weeks
Gluthathione
MRS scan to measure gluthathione
Measured: 12 weeks
Plasma Glucose
MRS scan to measure plasma glucose
Measured: 0 weeks
Plasma Glucose
MRS scan to measure plasma glucose
Measured: 12 weeks
Plasma Fructose
MRS scan to measure plasma fructose
Measured: 0 weeks
Plasma Fructose
MRS scan to measure plasma fructose
Measured: 12 weeks
Plasma Insulin
MRS scan to measure plasma insulin
Measured: 0 weeks
Plasma Insulin
MRS scan to measure plasma insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start18 Jan 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperglycaemia (Diabetic)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Hwang, MD, Principal investigator, Section of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469492
- Sponsor's protocol ID
- 1602017151
- Other IDs
- 1K23DK109284-01
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2018
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5.
PubMed 35247067
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study
- ClinicalTrials.gov ID
- NCT03469492
- Acronym / sponsor ID
- 1602017151
- Conditions
- Hyperglycaemia (Diabetic)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 2 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.
Detailed description
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes mellitus | Active comparator | Drug: Insulin, Behavioral: exercise, Dietary Supplement: Dietary counselingSubjects with type 2 diabetes on insulin. |
| type 1 diabetes mellitus | Active comparator | Drug: Insulin, Behavioral: exercise, Dietary Supplement: Dietary counselingSubjects with type 1 diabetes on insulin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 15 Type 2 DM subjects with HbA1C > 7.5%
- 15 Type 1 DM subjects with HbA1C > 7.5%
- Age 18-60
- BMI ≥18 kg/m2
- Weight ≤ 285 pounds
Key exclusion criteria (11 listed)
- Creatinine > 1.5 mg/dL, Hgb < 10 mg/dL, ALT > 2.5 X ULN,
- untreated thyroid disease,
- uncontrolled hypertension,
- known neurological disorders,
- untreated psychiatric disorders,
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 |
|---|---|---|
| InsulinInsulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. | Drug | type 1 diabetes mellitus, type 2 diabetes mellitus |
| exerciseExercise in accordance to the guidelines established by the American Diabetes Association. | Behavioural | type 1 diabetes mellitus, type 2 diabetes mellitus |
| Dietary counselingDietary counseling in accordance to the guidelines established by the American Diabetes Association. | Dietary supplement | type 1 diabetes mellitus, type 2 diabetes mellitus |
Primary outcome
Change in HbA1c Levels
Time frame: Baseline and 12 weeks
HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.
8 secondary outcomes
Gluthathione
Time frame: 0 weeks
Gluthathione
Time frame: 12 weeks
Plasma Glucose
Time frame: 0 weeks
Plasma Glucose
Time frame: 12 weeks
Plasma Fructose
Time frame: 0 weeks
Plasma Fructose
Time frame: 12 weeks
Plasma Insulin
Time frame: 0 weeks
Plasma Insulin
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35247067Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5.
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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.
Janice Hwang, MD principal investigator
Section of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin, exercise and Dietary counseling in people with Hyperglycaemia (Diabetic), 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 5 inclusion and 11 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 5 Feb 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in HbA1c Levels (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469492, which also lists 1 linked publication.
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 5 Feb 2024.