Status:
COMPLETED
Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
Lead Sponsor:
Mondelēz International, Inc.
Collaborating Sponsors:
Provident Clinical Research
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
Eligibility Criteria
Inclusion
- 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
- 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.
- Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
- Pregnancy
- Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
- Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00907075
Start Date
March 1 2009
End Date
September 1 2009
Last Update
August 22 2012
Active Locations (2)
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1
Provident Clinical Research & Consulting, Inc.
Addison, Illinois, United States, 60101
2
Provident Clinical Research & Consulting, Inc.
Bloomington, Indiana, United States, 47403