Diabetes Mellitus, Type 2 Clinical Trial
NCT number | NCT01178723 |
Other study ID # | TASMC10JW0080CTIL |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | August 8, 2010 |
Last updated | August 8, 2010 |
Studies has found a connection between breakfast consumption and obesity and obesity-related
complications, but only few studies examined the effect of breakfast size.
The purpose of this study is to examine the effect of breakfast size on several parameters
in adults with Type 2 diabetes mellitus.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Men and women ages: 30-70 - Type 2 diabetics who are treated on a diet and / or pills - Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research) - Obese or overweight (35> BMI> 25) - Patients who did not participate in another research for at least 30 days - Patients who agree to sign a consent form and participate in research - Patients with high compliance. Exclusion Criteria: - Patients under the age 30 or over 70 - Type 1 I diabetics - Patients who are insulin dependent - Type 2 diabetics who are treated with injections - BMI less than 25 or BMI over 35 - Patients who had Bariatric surgery - Patients with food absorption disorders - Active malignant disease - Thyroid function disorder - Active psychiatric illness - Pregnancy / breastfeeding |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Israel | Diabetes Unit, Wolfson Medical Center | Holon | |
Israel | Diabetes Unit, Wolfson Medical Center | Holon |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood glucose balance | HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark | three months | No |
Secondary | anthropometric parameters | weight, height, body composition | three months | No |
Secondary | Adipokines and hormones | insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol | three months | No |
Secondary | pro-inflammatory cytokines | TNF-a, IL-6, MCP-1, CRP | three months | No |
Secondary | lipid profile | triglycerides, cholesterol, LDL, HDL | three months | No |
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