Evaluation of Glucose Control in Patients With Diabetes

Glycemic Control Clinical Trial

Official title:

A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230889
• Other study ID #: BL34
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glycemic Control

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