Glycemic ControlNCT04230889
Evaluation of Glucose Control in Patients With Diabetes
A study testing Usual Diet Group, Group 1 Nutritional Shake and Group 2 Nutritional Shake in people with Glycemic Control, run by Abbott Nutrition at 8 sites in United States.
Trial summary
A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycemic Control
- What is being tested?
- Usual Diet Group, Group 1 Nutritional Shake and Group 2 Nutritional Shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Feb 2017to 15 Feb 2018
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes as evidenced by the use of metformin, thiazolidinones, or sulfonylureas, alone or in combination, with constant dose for a least 2 months prior to Screening and is able to maintain medication dose throughout the duration of the study
- A1C ≥ 7.0% and ≤ 10.0%
- Follows a consistent eating pattern of 3 main meals with snacks
- BMI ≥ 25.0 and ≤ 40.0 kg/m2
- Stable body weight for the past 2 months prior to Screening Visit
- If on thyroid medication or hormone replacement therapy, dose been has been constant for at least 2 months prior to Screening Visit
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- If taking vitamin C supplement >60 mg/d, is willing to discontinue throughout the duration of the study
- Willing to take non-aspirin pain relievers through the duration of the study
- Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- Not taking oral anti-hyperglycemic medications (e.g., controlled by diet); is taking other oral anti-hyperglycemic medications other than metformin, thiazolidinones, or sulfonylureas; or on injectable medications (e.g., exenatide, insulin) for glucose control
- History of diabetic ketoacidosis
- History of metabolic/endocrine (other than diabetes), hepatic, or significant renal disease
- Follows a non-typical eating pattern, such as very low carbohydrate diet, strict vegetarianism
- Currently using diabetes-specific nutritional product(s), defined as more than one eating occasions per week
- Non-typical or erratic sleep-wake pattern, such as nightshift worker, chronic insomnia
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- Pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration (only applicable to female subjects)
- Skin lesions, hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that in the opinion of the study investigator or study physician could interfere with device placement or the accuracy of interstitial glucose measurements
- X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends
- Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Screening Visit
- Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
- Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
- History of bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., crohns, colitis, celiac) or intestinal surgery that can interfere with consumption/digestion/absorption of study product
- Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise; including heavy physical labor), duration of 1 hour or longer, 3 or more times per week
- Known to be allergic or intolerant to any ingredient found in the study products
- Currently taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite
- Eating disorder, severe dementia or delirium, 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
- Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
MB Clinical Research
Boca Raton, Florida, 33487
Joslin Diabetes Center
Boston, Massachusetts, 02215
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Radiant Research, Inc.
Cincinnati, Ohio, 45236
Rocky Mountain Daibetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Health Partners Institute, International Diabetes Center
Minneapolis, Minnesota, 55416
Radiant Clinical Research
Pinellas Park, Florida, 33781
Radiant Research
Scottsdale, Arizona, 85251
About this study
Official title: A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.
- Conditions
- Glycemic Control
- Being tested
- Usual Diet Group, Group 1 Nutritional Shake, Group 2 Nutritional Shake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Diet GroupOther
three main meals and two snacks
Group 1 Nutritional ShakeOther
2 servings per day
Group 2 Nutritional ShakeOther
2 servings per day
| Study group | Role | What they receive |
|---|---|---|
| Usual Diet Group | Other | Instructed to continue to maintain a diet pattern of three main meals (breakfast, lunch and dinner) with two daily snacks including a usual snack (of their own choosing) mid-morning and a usual snack (of their own choosing) mid-afternoon. Receives: Other: Usual Diet Group |
| Group 1 Nutritional Shake | Experimental | Instructed to consume one nutrition shake instead of their usual breakfast and consume the second nutrition shake for their mid-afternoon snack. Receives: Other: Group 1 Nutritional Shake |
| Group 2 Nutritional Shake | Experimental | Instructed to consume one Study Shake instead of their usual breakfast and the second Study Shake for the second snack before bed-time. Receives: Other: Group 2 Nutritional Shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial Glucose Response
Change versus baseline phase
Measured: Study Day 1 to Study Day 14
Secondary outcomes (1)
Postprandial Glucose
Change in daily total glucose
Measured: Study Day 1 to Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Feb 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
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 Glycemic ControlStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230889
- Sponsor's protocol ID
- BL34
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mustad VA, Hegazi RA, Hustead DS, Budiman ES, Rueda R, Maki K, Powers M, Mechanick JI, Bergenstal RM, Hamdy O. Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001258. doi: 10.1136/bmjdrc-2020-001258.
PubMed 32718934
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04230889
- Acronym / sponsor ID
- BL34
- Conditions
- Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 18 Jan 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.
A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Diet Group | Other | Other: Usual Diet GroupInstructed to continue to maintain a diet pattern of three main meals (breakfast, lunch and dinner) with two daily snacks including a usual snack (of their own choosing) mid-morning and a usual snack (of their own choosing) mid-afternoon. |
| Group 1 Nutritional Shake | Experimental | Other: Group 1 Nutritional ShakeInstructed to consume one nutrition shake instead of their usual breakfast and consume the second nutrition shake for their mid-afternoon snack. |
| Group 2 Nutritional Shake | Experimental | Other: Group 2 Nutritional ShakeInstructed to consume one Study Shake instead of their usual breakfast and the second Study Shake for the second snack before bed-time. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes as evidenced by the use of metformin, thiazolidinones, or sulfonylureas, alone or in combination, with constant dose for a least 2 months prior to Screening and is able to maintain medication dose throughout the duration of the study
- A1C ≥ 7.0% and ≤ 10.0%
- Follows a consistent eating pattern of 3 main meals with snacks
- BMI ≥ 25.0 and ≤ 40.0 kg/m2
- Stable body weight for the past 2 months prior to Screening Visit
Key exclusion criteria (18 listed)
- Not taking oral anti-hyperglycemic medications (e.g., controlled by diet); is taking other oral anti-hyperglycemic medications other than metformin, thiazolidinones, or sulfonylureas; or on injectable medications (e.g., exenatide, insulin) for glucose control
- History of diabetic ketoacidosis
- History of metabolic/endocrine (other than diabetes), hepatic, or significant renal disease
- Follows a non-typical eating pattern, such as very low carbohydrate diet, strict vegetarianism
- Currently using diabetes-specific nutritional product(s), defined as more than one eating occasions per week
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 |
|---|---|---|
| Usual Diet Groupthree main meals and two snacks | Other | Usual Diet Group |
| Group 1 Nutritional Shake2 servings per day | Other | Group 1 Nutritional Shake |
| Group 2 Nutritional Shake2 servings per day | Other | Group 2 Nutritional Shake |
Primary outcome
Interstitial Glucose Response
Time frame: Study Day 1 to Study Day 14
Change versus baseline phase
1 secondary outcome
Postprandial Glucose
Time frame: Study Day 1 to Study Day 14
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 18 Jan 2020.
- Derived from this study: PubMed 32718934Mustad VA, Hegazi RA, Hustead DS, Budiman ES, Rueda R, Maki K, Powers M, Mechanick JI, Bergenstal RM, Hamdy O. Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001258. doi: 10.1136/bmjdrc-2020-001258.
- 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.
Vikkie Mustad, PhD study chair
Abbott Nutrition
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Diet Group, Group 1 Nutritional Shake and Group 2 Nutritional Shake in people with Glycemic Control, run by Abbott Nutrition at 8 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 9 inclusion and 18 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Interstitial Glucose Response (time frame: Study Day 1 to Study Day 14). 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 NCT04230889, 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 18 Jan 2020.