Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

Mondelēz International, Inc.1 site in 1 country51 target enrollmentMarch 2009

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Mondelēz International, Inc.
Enrollment: 51
Locations: 1
Primary Endpoint: Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

September 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mondelēz International, Inc.

Eligibility Criteria

Inclusion Criteria

•Male or female, 18-79 years of age, inclusive.
•Diagnosis of type 2 diabetes, at least nine months prior to screening.
•Stable use of oral hypoglycemic medication for at least two months prior to screening.
•Body mass index (BMI) ≥25.0 and \<45.0 kg/m2 at screening.
•Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.

Exclusion Criteria

•History or diagnosis of type 1 diabetes mellitus.
•Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
•Weight loss or gain \>10 lb (4.5 kg) in the two months prior to screening.
•Abnormal laboratory test results of clinical importance.
•History of gastrointestinal surgery for weight-reducing purposes.
•Poorly controlled hypertension.
•A clinically important medical or other condition.
•Any major trauma or major surgical event within three months of screening.
•Use of injected medications for glucose control within four weeks prior to screening.
•Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.

Outcomes

Primary Outcomes

Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).

Time Frame: 10 weeks

Secondary Outcomes

Change in 24 hour mean circulating glucose level from baseline to end of treatment.(10 weeks)
Change in fasting plasma glucose and insulin from baseline to end of treatment.(10 weeks)
Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.(10 weeks)
Change in dietary macronutrient composition from baseline to end of treatment.(10 weeks)