DiabetesNCT02898766
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
A study testing Enteral Nutrition Formula in people with Diabetes, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Enteral Nutrition Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-75 yrs
- Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
Who cannot join
- Abnormal thyroid function
- Creatinine >2.0 mg/dL
- Potassium <3.5 mEq/L
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
- Patients currently on any anti-coagulant medication
Show all 13Show fewer
- Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
- Unable to give informed consent or follow instructions
- Current insulin therapy or insulin therapy within the past month
- Patient who are pregnant
- Allergies to milk, fish oil or any component of the test product
- Patient who in the Investigators assessment cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
Official title: Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.
- Conditions
- Diabetes
- Being tested
- Enteral Nutrition Formula
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Nutrition FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition Formula 1 | Active comparator | Enteral Nutrition Formula Receives: Other: Enteral Nutrition Formula |
| Enteral Nutrition Formula 2 | Active comparator | Enteral Nutrition Formula Receives: Other: Enteral Nutrition Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the blood glucose curve (AUC 0-240)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes (3)
Area under the insulin curves (AUC 0-240)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30))
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898766
- Sponsor's protocol ID
- 16.17.CLI
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02898766
- Acronym / sponsor ID
- 16.17.CLI
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Sep 2016 (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.
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition Formula 1 | Active comparator | Other: Enteral Nutrition FormulaEnteral Nutrition Formula |
| Enteral Nutrition Formula 2 | Active comparator | Other: Enteral Nutrition FormulaEnteral Nutrition Formula |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-75 yrs
- Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
Key exclusion criteria (13 listed)
- Abnormal thyroid function
- Creatinine >2.0 mg/dL
- Potassium <3.5 mEq/L
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
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 |
|---|---|---|
| Enteral Nutrition Formula | Other | Enteral Nutrition Formula 1, Enteral Nutrition Formula 2 |
Primary outcome
Area under the blood glucose curve (AUC 0-240)
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
3 secondary outcomes
Area under the insulin curves (AUC 0-240)
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30))
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
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 11 Oct 2016.
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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.
Joel Neutel, MD principal investigator
Orange County Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Nutrition Formula in people with Diabetes, run by Société des Produits Nestlé (SPN) 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 4 inclusion and 13 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 11 Oct 2016. 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?
Area under the blood glucose curve (AUC 0-240) (time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes). 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 11 Oct 2016.