Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
NCT ID: NCT00907075
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2009-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NES With Energy Restriction
NES With Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.
NES Without Energy Restriction
NES Without Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement.
Interventions
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NES With Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.
NES Without Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of type 2 diabetes, at least nine months prior to screening.
3. Stable use of oral hypoglycemic medication for at least two months prior to screening.
4. Body mass index (BMI) ≥25.0 and \<45.0 kg/m2 at screening.
5. Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.
Exclusion Criteria
2. Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
3. Weight loss or gain \>10 lb (4.5 kg) in the two months prior to screening.
4. Abnormal laboratory test results of clinical importance.
5. History of gastrointestinal surgery for weight-reducing purposes.
6. Poorly controlled hypertension.
7. A clinically important medical or other condition.
8. Any major trauma or major surgical event within three months of screening.
9. Use of injected medications for glucose control within four weeks prior to screening.
10. Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
11. Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
12. Pregnancy
13. Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
14. Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
18 Years
79 Years
ALL
No
Sponsors
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Provident Clinical Research
OTHER
Mondelēz International, Inc.
INDUSTRY
Responsible Party
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Kraft Foods
Principal Investigators
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Kevin C Maki, PhD
Role: STUDY_DIRECTOR
Provident Clinical Research & Consulting, Inc.
Locations
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Provident Clinical Research & Consulting, Inc.
Addison, Illinois, United States
Provident Clinical Research & Consulting, Inc.
Bloomington, Indiana, United States
Countries
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Other Identifiers
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PRV-08012V1.9
Identifier Type: -
Identifier Source: secondary_id
PRV-08012
Identifier Type: -
Identifier Source: org_study_id