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

Mondelez International

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: NES Without Energy Restriction; Behavioral: NES With Energy Restriction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00907075

PRV-08012V1.9

PRV-08012

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

NES With Energy Restriction

Active Comparator group

Treatment:

Behavioral: NES With Energy Restriction

NES Without Energy Restriction

Active Comparator group

Treatment:

Behavioral: NES Without Energy Restriction