Clinical trial NCT00907075: Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
Official title: Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
nutrition
diet
foods
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Provident Clinical Research
First posted: 2009-05-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Male or female, 18-79 years of age, inclusive.
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:

1. History or diagnosis of type 1 diabetes mellitus.
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.

Primary outcomes:
measure: 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).
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in 24 hour mean circulating glucose level from baseline to end of treatment.
timeFrame: 10 weeks
measure: Change in fasting plasma glucose and insulin from baseline to end of treatment.
timeFrame: 10 weeks
measure: Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.
timeFrame: 10 weeks
measure: Change in dietary macronutrient composition from baseline to end of treatment.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Provident Clinical Research & Consulting, Inc.
state: Illinois
city: Bloomington
country: United States
facility: Provident Clinical Research & Consulting, Inc.
state: Indiana
Study officials:
affiliation: Provident Clinical Research & Consulting, Inc.
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References: