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Evaluation of Glucose Control in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04230889
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Abbott Nutrition

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.

Condition or disease Intervention/treatment Phase
Glycemic Control Other: Usual Diet Group Other: Group 1 Nutritional Shake Other: Group 2 Nutritional Shake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Usual Diet Group
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.
Other: Usual Diet Group
three main meals and two snacks

Experimental: Group 1 Nutritional Shake
Instructed to consume one nutrition shake instead of their usual breakfast and consume the second nutrition shake for their mid-afternoon snack.
Other: Group 1 Nutritional Shake
2 servings per day

Experimental: Group 2 Nutritional Shake
Instructed to consume one Study Shake instead of their usual breakfast and the second Study Shake for the second snack before bed-time.
Other: Group 2 Nutritional Shake
2 servings per day

Primary Outcome Measures :
  1. Interstitial Glucose Response [ Time Frame: Study Day 1 to Study Day 14 ]
    Change versus baseline phase

Secondary Outcome Measures :
  1. Postprandial Glucose [ Time Frame: Study Day 1 to Study Day 14 ]
    Change in daily total glucose

Other Outcome Measures:
  1. Nutrition Behaviors Self-Reported Outcome Questionnaire [ Time Frame: Study Day 1 to Study Day 14 ]
    15 Likert scale questions related to diet selection, oral nutritional supplement use, cravings and hunger control

  2. Physical Activity Questionnaire [ Time Frame: Study Day 1 ]
    Adapted from National Health Interview Survey; Subject completed; 3 questions related to description of typical physical activity

  3. Habitual Snack Timing Questionnaire [ Time Frame: Study Day 1 ]
    Subject completed; 3 questions related to frequency, timing and reason for snacking

  4. Daily Tracking Log [ Time Frame: Study Day 1 to Study Day 14 ]
    Subject reported log of sleeping, exercise and eating information

  5. Weight [ Time Frame: Study Day 1 to Study Day 14 ]
    Measured in kg

  6. Height [ Time Frame: Study Day 1 ]
    Measured in cm

  7. Waist Circumference [ Time Frame: Study Day 1 ]
    Measured in inches

  8. Medications [ Time Frame: Study Day 1 to Study Day 14 ]
    Subject reported medication usage including dose, unit, frequency and reason for use

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04230889

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United States, Arizona
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, Florida
MB Clinical Research
Boca Raton, Florida, United States, 33487
Radiant Clinical Research
Pinellas Park, Florida, United States, 33781
United States, Idaho
Rocky Mountain Daibetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Health Partners Institute, International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45236
Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Vikkie Mustad, PhD Abbott Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abbott Nutrition Identifier: NCT04230889    
Other Study ID Numbers: BL34
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No