Evaluation of Glucose Control in Patients With Diabetes

NCT04230889 | Completed

• 1 other identifier: BL34
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 8

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.

Conditions

Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Interstitial Glucose Response

  Change versus baseline phase

  Study Day 1 to Study Day 14

Secondary Outcomes (1)

• Postprandial Glucose

  Study Day 1 to Study Day 14

Other Outcomes (8)

• Nutrition Behaviors Self-Reported Outcome Questionnaire

  Study Day 1 to Study Day 14

• Physical Activity Questionnaire

  Study Day 1

• Habitual Snack Timing Questionnaire

  Study Day 1

Study Arms (3)

Usual Diet Group

OTHER

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

Group 1 Nutritional Shake

EXPERIMENTAL

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

Group 2 Nutritional Shake

EXPERIMENTAL

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

Interventions

Usual Diet Group OTHER

three main meals and two snacks

Usual Diet Group

Group 1 Nutritional Shake OTHER

2 servings per day

Group 1 Nutritional Shake

Group 2 Nutritional Shake OTHER

2 servings per day

Group 2 Nutritional Shake

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (8)

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

Radiant Clinical Research

Pinellas Park, Florida, 33781, United States

Location

Rocky Mountain Daibetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Health Partners Institute, International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45236, United States

Location

Related Publications (1)

• 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.

  PMID: 32718934 DERIVED

Study Officials

• Vikkie Mustad, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: February 6, 2017
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)