NCT02691481

Brief Summary

Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma glucose is not yet known. The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty acids (FFA) and serum triglycerides (TG).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 22, 2016

Last Update Submit

February 22, 2016

Conditions

Type 2 Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (1)

  • Glucose area under the curve 0-240 minutes

    240 minutes

Study Arms (3)

Oatmeal breakfast

ACTIVE COMPARATOR

consuming 200 kcal of plain cooked oatmeal for breakfast

Dietary Supplement: Oatmeal breakfastDietary Supplement: Glucerna formulaDietary Supplement: Ultra Glucose Control formula

Glucerna formula

ACTIVE COMPARATOR

consuming 200 kcal of Glucerna shake for breakfast

Dietary Supplement: Oatmeal breakfastDietary Supplement: Glucerna formulaDietary Supplement: Ultra Glucose Control formula

Ultra Glucose Control formula

ACTIVE COMPARATOR

consuming 200 kcal of Ultra Glucose Control shake for breakfast

Dietary Supplement: Oatmeal breakfastDietary Supplement: Glucerna formulaDietary Supplement: Ultra Glucose Control formula

Interventions

Oatmeal breakfastDIETARY_SUPPLEMENT
Glucerna formulaOatmeal breakfastUltra Glucose Control formula
Glucerna formulaDIETARY_SUPPLEMENT
Glucerna formulaOatmeal breakfastUltra Glucose Control formula
Ultra Glucose Control formulaDIETARY_SUPPLEMENT
Glucerna formulaOatmeal breakfastUltra Glucose Control formula

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes treated with oral diabetes medications

You may not qualify if:

  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share