DiabetesNCT02612675
Glycemic Response to Oral Nutrition Supplements
A study testing ONS 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 study of two oral nutrition supplements in individuals with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2013
- 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/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
Who cannot join
- Allergy to milk protein or any other component of the formula
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes & Glandular Disease Clinic, PA
San Antonio, Texas, 78229-4801
About this study
Official title: Plasma Glucose and Insulin Response to Two Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.
- Conditions
- Diabetes
- Being tested
- ONS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSOther
| Study group | Role | What they receive |
|---|---|---|
| Standard ONS | Active comparator | Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption Receives: Other: ONS |
| Low Carbohydrate ONS | Experimental | Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption Receives: Other: ONS |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherwyn Schwartz, MD, Principal investigator, Diabetes & Glandular Disease Clinic, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612675
- Sponsor's protocol ID
- 13.10.US.HCN
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Huhmann MB, Smith KN, Schwartz SL, Haller SK, Irvin S, Cohen SS. Plasma glucose and insulin response to two oral nutrition supplements in adults with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000240. doi: 10.1136/bmjdrc-2016-000240. eCollection 2016.
PubMed 27648290
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucose and Insulin Response to Two Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02612675
- Acronym / sponsor ID
- 13.10.US.HCN
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Nov 2015 (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 study of two oral nutrition supplements in individuals with Type 2 Diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ONS | Active comparator | Other: ONSNutritional beverage (Oral Nutrition Supplement) designed for oral consumption |
| Low Carbohydrate ONS | Experimental | Other: ONSNutritional beverage (Oral Nutrition Supplement) designed for oral consumption |
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/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
Key exclusion criteria (1 listed)
- Allergy to milk protein or any other component of the formula
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 |
|---|---|---|
| ONS | Other | Low Carbohydrate ONS, Standard ONS |
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
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 24 Nov 2015.
- Derived from this study: PubMed 27648290Huhmann MB, Smith KN, Schwartz SL, Haller SK, Irvin S, Cohen SS. Plasma glucose and insulin response to two oral nutrition supplements in adults with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000240. doi: 10.1136/bmjdrc-2016-000240. eCollection 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.
Sherwyn Schwartz, MD principal investigator
Diabetes & Glandular Disease Clinic, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS 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 1 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 24 Nov 2015. 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?
On the ClinicalTrials.gov record for NCT02612675, 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 24 Nov 2015.