Diabetes Mellitus, Type 2NCT05026424
Glycemic Response in Adults with Diabetes
A study testing Balance oral nutritional drink - test in people with Diabetes Mellitus, Type 2, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This will be a randomized crossover design with oral nutrition supplement interventions. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Balance oral nutritional drink - test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 5 Oct 2021
- 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 years
- Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg/dl
- Hematocrit levels within normal limits
- Having obtained his/her informed consent
Who cannot join
- Abnormal thyroid function
- Creatinine >2.0 mg/dl
- Potassium <3.5 mEq/l
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
- Patients with anemia
Show all 12Show fewer
- Current insulin therapy or insulin therapy within the past month
- Patient who are pregnant
- Allergies to milk, soy or any component of the test product
- Patient who in the investigators assessment cannot be expected to comply with treatment
- Patients with anemia
- Currently participating 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: Glucose and Insulin Response in Adults with Type 2 Diabetes
This will be a randomized crossover design with oral nutrition supplement interventions.
Read the detailed description
This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Balance oral nutritional drink - control, Balance oral nutritional drink - test
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance oral nutritional drink - controlOther
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Balance oral nutritional drink - testOther
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Oral Nutrition Supplement Control | Placebo comparator | The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition. Receives: Other: Balance oral nutritional drink - control |
| Active Comparator: Oral Nutrition Supplement Test | Active comparator | The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes. Receives: Other: Balance oral nutritional drink - test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glycemic markers
Area under the blood glucose curve (AUC 0-240 minutes)
Measured: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Secondary outcomes (2)
Post-prandial insulin markers
Area under the insulin curve (AUC 0-240 minutes)
Measured: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Insulinogenic index
Insulinogenic index (change in Ins30/change in Glu30)
Measured: [Time Frame: 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 posted30 Aug 2021
- Study start2 Aug 2021
- Primary completion30 Sep 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Model description
- This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krysmaru Araujo Torres, MD, Study director, Nestle Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026424
- Sponsor's protocol ID
- 21.04.US.HCN
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2021
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose and Insulin Response in Adults with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05026424
- Acronym / sponsor ID
- 21.04.US.HCN
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- 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 crossover design with oral nutrition supplement interventions.
Detailed description
This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Oral Nutrition Supplement Control | Placebo comparator | Other: Balance oral nutritional drink - controlThe control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition. |
| Active Comparator: Oral Nutrition Supplement Test | Active comparator | Other: Balance oral nutritional drink - testThe test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20-75 years
- Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg/dl
- Hematocrit levels within normal limits
Key exclusion criteria (12 listed)
- Abnormal thyroid function
- Creatinine >2.0 mg/dl
- Potassium <3.5 mEq/l
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
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 |
|---|---|---|
| Balance oral nutritional drink - controlDrink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition. | Other | Active Comparator: Oral Nutrition Supplement Control |
| Balance oral nutritional drink - testDrink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition. | Other | Active Comparator: Oral Nutrition Supplement Test |
Primary outcome
Post-prandial glycemic markers
Time frame: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Area under the blood glucose curve (AUC 0-240 minutes)
2 secondary outcomes
Post-prandial insulin markers
Time frame: [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Insulinogenic index
Time frame: [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 21 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Krysmaru Araujo Torres, MD study director
Nestle Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance oral nutritional drink - test in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 12 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 21 Oct 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. Some participants in this study may receive a placebo. 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?
Post-prandial glycemic markers (time frame: [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 21 Oct 2024.