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Evaluation of Glucose Control in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT04230889
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Tracking Information
First Submitted Date  ICMJE January 6, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE February 6, 2017
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
Interstitial Glucose Response [ Time Frame: Study Day 1 to Study Day 14 ]
Change versus baseline phase
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
Postprandial Glucose [ Time Frame: Study Day 1 to Study Day 14 ]
Change in daily total glucose
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 13, 2020)
  • 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
  • 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
  • Habitual Snack Timing Questionnaire [ Time Frame: Study Day 1 ]
    Subject completed; 3 questions related to frequency, timing and reason for snacking
  • Daily Tracking Log [ Time Frame: Study Day 1 to Study Day 14 ]
    Subject reported log of sleeping, exercise and eating information
  • Weight [ Time Frame: Study Day 1 to Study Day 14 ]
    Measured in kg
  • Height [ Time Frame: Study Day 1 ]
    Measured in cm
  • Waist Circumference [ Time Frame: Study Day 1 ]
    Measured in inches
  • Medications [ Time Frame: Study Day 1 to Study Day 14 ]
    Subject reported medication usage including dose, unit, frequency and reason for use
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Glucose Control in Patients With Diabetes
Official Title  ICMJE A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Glycemic Control
Intervention  ICMJE
  • Other: Usual Diet Group
    three main meals and two snacks
  • Other: Group 1 Nutritional Shake
    2 servings per day
  • Other: Group 2 Nutritional Shake
    2 servings per day
Study Arms  ICMJE
  • 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.
    Intervention: Other: Usual Diet Group
  • 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.
    Intervention: Other: Group 1 Nutritional Shake
  • 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.
    Intervention: Other: Group 2 Nutritional Shake
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). pii: e001258. doi: 10.1136/bmjdrc-2020-001258.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2020)
125
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 15, 2018
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04230889
Other Study ID Numbers  ICMJE BL34
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Nutrition
Study Sponsor  ICMJE Abbott Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Vikkie Mustad, PhD Abbott Nutrition
PRS Account Abbott Nutrition
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP