Glycemic Control
Conditions
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.
Interventions
OTHERUsual Diet Group
three main meals and two snacks
OTHERGroup 1 Nutritional Shake
2 servings per day
OTHERGroup 2 Nutritional Shake
2 servings per day
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interstitial Glucose Response | Study Day 1 to Study Day 14 | Change versus baseline phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glucose | Study Day 1 to Study Day 14 | Change in daily total glucose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Habitual Snack Timing Questionnaire | Study Day 1 | Subject completed; 3 questions related to frequency, timing and reason for snacking |
| Daily Tracking Log | Study Day 1 to Study Day 14 | Subject reported log of sleeping, exercise and eating information |
| Weight | Study Day 1 to Study Day 14 | Measured in kg |
| Nutrition Behaviors Self-Reported Outcome Questionnaire | Study Day 1 to Study Day 14 | 15 Likert scale questions related to diet selection, oral nutritional supplement use, cravings and hunger control |
| Waist Circumference | Study Day 1 | Measured in inches |
| Medications | Study Day 1 to Study Day 14 | Subject reported medication usage including dose, unit, frequency and reason for use |
| Height | Study Day 1 | Measured in cm |
| Physical Activity Questionnaire | Study Day 1 | Adapted from National Health Interview Survey; Subject completed; 3 questions related to description of typical physical activity |
Countries
United States
Outcome results
None listed