DiabetesNCT02923960
Effect of Nutritional Products in Subjects With Type 2 Diabetes
A study testing Standard ONS, Diabetes specific ONS 1 and Diabetes specific ONS 2 in people with Diabetes, run by Abbott Nutrition at 2 sites in United States.
Trial summary
This is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Standard ONS, Diabetes specific ONS 1 and Diabetes specific ONS 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Jan 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has type 2 diabetes
- Subject is a male or a nonpregnant, nonlactating female, at least 6 weeks postpartum prior to screening visit
- Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2
- If on a chronic medication such as antihypertensive, lipid lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit
- Subject states willingness to follow protocol as described, including consumption of study product per protocol and completing any required study forms
- Participant must refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism (other than oral hypoglycemic medications), or considered anabolic, or reduce weight (fat mass)
Who cannot join
- Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Subject is known to be allergic or intolerant to any ingredient found in the study products
- Subject is participating in another study that has not been approved as a concomitant study
- Subject uses exogenous insulin for glucose control, or subject states that they have been diagnosed as having Type 1 diabetes
- Subject states they have a history of diabetic ketoacidosis
- Subject is currently on a low carbohydrate or very low carbohydrate diet
Show all 21Show fewer
- Subject states that he/she has a current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit
- Subject states that he/she has an active malignancy
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure
- Subject states that he/she has end stage organ failure or is status post organ transplant
- Subject is diagnosed with chronic kidney disease, or a history of kidney issues
- Subject states they have impaired liver function, or have a history of liver disease
- Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, or ischemic colitis, or any other related condition that may cause unnecessary subject discomfort
- Subject states they have a chronic, contagious, infectious disease
- Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that are designed to affect blood glucose.
- Subject states that he/she has clotting or bleeding disorders
- If selected for continuous blood glucose monitoring, subject has skin lesions, hyperhidrosis, eczema, psoriasis, scarring, redness, infection or edema at the flash constant glucose monitoring application site(s) that could interfere with device placement or the accuracy of interstitial glucose measurements.
- If selected for continuous blood glucose monitoring, subject has an X-ray, MRI or CT appointment scheduled during the period of study participation, or another procedure that would require removal of the flash constant glucose monitoring sensor.
- Subjects on sulfonylureas, meglitinides, and α-glucosidase inhibitors, insulin, or subject on more than two oral hypoglycemic medications excluding aforementioned.
- Subjects on oral hypoglycemic medications that has changed in last 2 months.
- Subject's HbA1c, per point of care device is > 8%
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Radiant Research, Inc.
Cincinnati, Ohio, 45236
About this study
Official title: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes
This is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people with type 2 diabetes.
- Conditions
- Diabetes
- Being tested
- Standard ONS, Diabetes specific ONS 1, Diabetes specific ONS 2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ONSOther
One serving (237 ml) standard oral nutritional beverage
Diabetes specific ONS 1Other
One serving (237 ml) diabetes oral nutritional beverage
Diabetes specific ONS 2Other
One serving (296 ml) diabetes oral nutritional beverage
| Study group | Role | What they receive |
|---|---|---|
| Standard ONS | Active comparator | liquid oral nutritional supplement Receives: Other: Standard ONS |
| Diabetes specific ONS 1 | Experimental | liquid oral nutritional supplement with novel carbohydrate blend Receives: Other: Diabetes specific ONS 1 |
| Diabetes specific ONS 2 | Active comparator | liquid oral nutritional supplement with novel carbohydrate blend Receives: Other: Diabetes specific ONS 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose Concentration
Measured: 0 to 240 minutes
Secondary outcomes (1)
Serum Insulin Concentration
Measured: 0 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Owen Kelly, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923960
- Sponsor's protocol ID
- BL33
- Status last verified
- Apr 2017
- First submitted
- 3 Oct 2016
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02923960
- Acronym / sponsor ID
- BL33
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Oct 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 is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people with type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ONS | Active comparator | Other: Standard ONSliquid oral nutritional supplement |
| Diabetes specific ONS 1 | Experimental | Other: Diabetes specific ONS 1liquid oral nutritional supplement with novel carbohydrate blend |
| Diabetes specific ONS 2 | Active comparator | Other: Diabetes specific ONS 2liquid oral nutritional supplement with novel carbohydrate blend |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has type 2 diabetes
- Subject is a male or a nonpregnant, nonlactating female, at least 6 weeks postpartum prior to screening visit
- Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2
- If on a chronic medication such as antihypertensive, lipid lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit
- Subject states willingness to follow protocol as described, including consumption of study product per protocol and completing any required study forms
Key exclusion criteria (21 listed)
- Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Subject is known to be allergic or intolerant to any ingredient found in the study products
- Subject is participating in another study that has not been approved as a concomitant study
- Subject uses exogenous insulin for glucose control, or subject states that they have been diagnosed as having Type 1 diabetes
- Subject states they have a history of diabetic ketoacidosis
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 |
|---|---|---|
| Standard ONSOne serving (237 ml) standard oral nutritional beverage | Other | Standard ONS |
| Diabetes specific ONS 1One serving (237 ml) diabetes oral nutritional beverage | Other | Diabetes specific ONS 1 |
| Diabetes specific ONS 2One serving (296 ml) diabetes oral nutritional beverage | Other | Diabetes specific ONS 2 |
Primary outcome
Plasma Glucose Concentration
Time frame: 0 to 240 minutes
1 secondary outcome
Serum Insulin Concentration
Time frame: 0 to 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 17 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Owen Kelly, PhD study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ONS, Diabetes specific ONS 1 and Diabetes specific ONS 2 in people with Diabetes, run by Abbott Nutrition at 2 sites 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 21 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma Glucose Concentration (time frame: 0 to 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 17 Apr 2017.