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Effect of Nutritional Products in Subjects With Type 2 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.
 
ClinicalTrials.gov Identifier: NCT02923960
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
This is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Other: Standard ONS Other: Diabetes specific ONS 1 Other: Diabetes specific ONS 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard ONS
liquid oral nutritional supplement
Other: Standard ONS
One serving (237 ml) standard oral nutritional beverage

Experimental: Diabetes specific ONS 1
liquid oral nutritional supplement with novel carbohydrate blend
Other: Diabetes specific ONS 1
One serving (237 ml) diabetes oral nutritional beverage

Active Comparator: Diabetes specific ONS 2
liquid oral nutritional supplement with novel carbohydrate blend
Other: Diabetes specific ONS 2
One serving (296 ml) diabetes oral nutritional beverage




Primary Outcome Measures :
  1. Plasma Glucose Concentration [ Time Frame: 0 to 240 minutes ]

Secondary Outcome Measures :
  1. Serum Insulin Concentration [ Time Frame: 0 to 240 minutes ]


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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has type 2 diabetes
  • Subject is a male or a nonpregnant, nonlactating female, at least 6 weeks postpartum prior to screening visit
  • Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2
  • If on a chronic medication such as antihypertensive, lipid lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit
  • Subject states willingness to follow protocol as described, including consumption of study product per protocol and completing any required study forms
  • Participant must refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism (other than oral hypoglycemic medications), or considered anabolic, or reduce weight (fat mass)

Exclusion Criteria:

  • Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, 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
  • Subject is known to be allergic or intolerant to any ingredient found in the study products
  • Subject is participating in another study that has not been approved as a concomitant study
  • Subject uses exogenous insulin for glucose control, or subject states that they have been diagnosed as having Type 1 diabetes
  • Subject states they have a history of diabetic ketoacidosis
  • Subject is currently on a low carbohydrate or very low carbohydrate diet
  • Subject states that he/she has a current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit
  • Subject states that he/she has an active malignancy
  • Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure
  • Subject states that he/she has end stage organ failure or is status post organ transplant
  • Subject is diagnosed with chronic kidney disease, or a history of kidney issues
  • Subject states they have impaired liver function, or have a history of liver disease
  • Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, or ischemic colitis, or any other related condition that may cause unnecessary subject discomfort
  • Subject states they have a chronic, contagious, infectious disease
  • Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that are designed to affect blood glucose.
  • Subject states that he/she has clotting or bleeding disorders
  • If selected for continuous blood glucose monitoring, subject has skin lesions, hyperhidrosis, eczema, psoriasis, scarring, redness, infection or edema at the flash constant glucose monitoring application site(s) that could interfere with device placement or the accuracy of interstitial glucose measurements.
  • If selected for continuous blood glucose monitoring, subject has an X-ray, MRI or CT appointment scheduled during the period of study participation, or another procedure that would require removal of the flash constant glucose monitoring sensor.
  • Subjects on sulfonylureas, meglitinides, and α-glucosidase inhibitors, insulin, or subject on more than two oral hypoglycemic medications excluding aforementioned.
  • Subjects on oral hypoglycemic medications that has changed in last 2 months.
  • Subject's HbA1c, per point of care device is > 8%

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 ClinicalTrials.gov identifier (NCT number): NCT02923960


Locations
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United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45236
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Owen Kelly, PhD Abbott Nutrition

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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02923960    
Other Study ID Numbers: BL33
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases