Clinical trial NCT04230889: Evaluation of Glucose Control in Patients With Diabetes
Official title: A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Control
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 125
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Interstitial Glucose Response
timeFrame: Study Day 1 to Study Day 14
Secondary outcomes:
measure: Postprandial Glucose
timeFrame: Study Day 1 to Study Day 14
Other outcomes:
measure: Nutrition Behaviors Self-Reported Outcome Questionnaire
timeFrame: Study Day 1 to Study Day 14
measure: Physical Activity Questionnaire
timeFrame: Study Day 1
measure: Habitual Snack Timing Questionnaire
timeFrame: Study Day 1
measure: Daily Tracking Log
timeFrame: Study Day 1 to Study Day 14
measure: Weight
timeFrame: Study Day 1 to Study Day 14
measure: Height
timeFrame: Study Day 1
measure: Waist Circumference
timeFrame: Study Day 1
measure: Medications
timeFrame: Study Day 1 to Study Day 14
Locations:
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Boca Raton
country: United States
facility: MB Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Daibetes and Osteoporosis Center
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Health Partners Institute, International Diabetes Center
state: Minnesota
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
citation: 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.