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

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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: NES With Energy Restriction
* Behavioral: NES Without Energy Restriction


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NES With Energy Restriction<br> | Behavioral: NES With Energy Restriction<br>* The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.<br>|
| Active Comparator: NES Without Energy Restriction<br> | Behavioral: NES Without Energy Restriction<br>* The NES will be administered based upon the individual's calculated daily energy requirement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, nutrition, diet, foods