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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04230889
Other study ID # BL34
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2017
Est. completion date February 15, 2018

Study information

Verified date January 2020
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date February 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Usual Diet Group
three main meals and two snacks
Group 1 Nutritional Shake
2 servings per day
Group 2 Nutritional Shake
2 servings per day

Locations

Country Name City State
United States MB Clinical Research Boca Raton Florida
United States Joslin Diabetes Center Boston Massachusetts
United States Great Lakes Clinical Trials Chicago Illinois
United States Radiant Research, Inc. Cincinnati Ohio
United States Rocky Mountain Daibetes and Osteoporosis Center Idaho Falls Idaho
United States Health Partners Institute, International Diabetes Center Minneapolis Minnesota
United States Radiant Clinical Research Pinellas Park Florida
United States Radiant Research Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Nutrition Behaviors Self-Reported Outcome Questionnaire 15 Likert scale questions related to diet selection, oral nutritional supplement use, cravings and hunger control Study Day 1 to Study Day 14
Other Physical Activity Questionnaire Adapted from National Health Interview Survey; Subject completed; 3 questions related to description of typical physical activity Study Day 1
Other Habitual Snack Timing Questionnaire Subject completed; 3 questions related to frequency, timing and reason for snacking Study Day 1
Other Daily Tracking Log Subject reported log of sleeping, exercise and eating information Study Day 1 to Study Day 14
Other Weight Measured in kg Study Day 1 to Study Day 14
Other Height Measured in cm Study Day 1
Other Waist Circumference Measured in inches Study Day 1
Other Medications Subject reported medication usage including dose, unit, frequency and reason for use Study Day 1 to Study Day 14
Primary Interstitial Glucose Response Change versus baseline phase Study Day 1 to Study Day 14
Secondary Postprandial Glucose Change in daily total glucose Study Day 1 to Study Day 14
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