Diabetes Mellitus, Type 2NCT04413357
Glycemic Response in Persons with Type 2 Diabetes
A study testing Balanced Nutritional Drink, Diabetes Specific, Balanced Nutritional Drink (DMA) and Diabetes Specific, Balanced Nutritional Drink DMB 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 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?
- Balanced Nutritional Drink, Diabetes Specific, Balanced Nutritional Drink (DMA) and Diabetes Specific, Balanced Nutritional Drink DMB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 11 Aug 2020
- 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
- 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
- Unable to give informed consent or follow instructions
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
- Currently participating or having participated in another clinical trial
- Patients with anemia
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 in Persons with Type 2 Diabetes Mellitus
This will be a randomized crossover design with nutrition supplement interventions.
Read the detailed description
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Balanced Nutritional Drink, Diabetes Specific, Balanced Nutritional Drink (DMA), Diabetes Specific, Balanced Nutritional Drink DMB
- 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.
Balanced Nutritional DrinkOther
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
Diabetes Specific, Balanced Nutritional Drink (DMA)Other
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 available in retail setting.
Diabetes Specific, Balanced Nutritional Drink DMBOther
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 |
|---|---|---|
| Balanced Nutritional Drink | Active comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition. Receives: Other: Balanced Nutritional Drink |
| Balanced Nutritional Drink - DMA | Active comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes. Receives: Other: Diabetes Specific, Balanced Nutritional Drink (DMA) |
| Balanced Nutritional Drink - DMB | Active comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes. Receives: Other: Diabetes Specific, Balanced Nutritional Drink DMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the blood glucose curve
Area under the blood glucose curve (AUC 0-240 minutes)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes (2)
Area under the insulin curves
Area under the insulin curves (AUC 0-240)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index
Insulinogenic index [Change in Ins30/Change in Glu30]
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 posted2 Jun 2020
- Study start18 May 2020
- Primary completion11 Jun 2020
- Study completion11 Aug 2020
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.
- 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 three interventions on three separate study days, one week apart.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 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
- NCT04413357
- Sponsor's protocol ID
- 19.01.US.HCN
- Status last verified
- Oct 2024
- First submitted
- 29 May 2020
- 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
- Plasma Glucose and Insulin Response in Persons with Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04413357
- Acronym / sponsor ID
- 19.01.US.HCN
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 2 Jun 2020 (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 nutrition supplement interventions.
Detailed description
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
| Arm | Type | Receives |
|---|---|---|
| Balanced Nutritional Drink | Active comparator | Other: Balanced Nutritional DrinkThe study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition. |
| Balanced Nutritional Drink - DMA | Active comparator | Other: Diabetes Specific, Balanced Nutritional Drink (DMA)The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes. |
| Balanced Nutritional Drink - DMB | Active comparator | Other: Diabetes Specific, Balanced Nutritional Drink DMBThe study interventions 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
- 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 |
|---|---|---|
| Balanced Nutritional DrinkDrink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition. | Other | Balanced Nutritional Drink |
| Diabetes Specific, Balanced Nutritional Drink (DMA)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 available in retail setting. | Other | Balanced Nutritional Drink - DMA |
| Diabetes Specific, Balanced Nutritional Drink DMBDrink 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 | Balanced Nutritional Drink - DMB |
Primary outcome
Area under the blood glucose curve
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
Area under the insulin curves
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index
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 Balanced Nutritional Drink, Diabetes Specific, Balanced Nutritional Drink (DMA) and Diabetes Specific, Balanced Nutritional Drink DMB 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. 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 (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.