Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Type 2 diabetic patients. • Individuals aged 21-60 years of either gender. • Obese (including morbid obesity) (BMI range: 30-50 kg/m2). • Currently undergoing treatment with oral antidiabetic agents, specifically on metformin for a duration of at least one year.
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Type 2 diabetic patients on insulin therapy. • Type 1 diabetic patients. • If the patient is currently on heavy Endurance Exercises. (Defined as Intense, prolonged activities lasting over 60 minutes.) • Major CVD, respiratory, psychiatric or musculoskeletal morbidity that will affect the patient adherence to the dietary intervention. Defined as (cardiovascular disease: Heart failure, STEMI and NSTEMI, Respiratory Disease: COPD, severe asthma, Psychiatric Disorder: Major depressive disorder, schizophrenia, Musculoskeletal Disorder: Rheumatoid arthritis.) • Severe hepatic impairment: liver dysfunction, defined as Child-Pugh score of B or C. • Severe renal impairment: Advanced kidney dysfunction, defined as a glomerular filtration rate (GFR) below 30 mL/min/1.73 m. • Pregnancy. • Alcoholic patients. • Hypothyroidism and hyperthyroidism (treated or newly diagnosed) • Current treatment with thyroxine or Antithyroid Medications as Methimazole and Propylthiouracil (PTU) • Systemic lupus patients • Current treatment with clarithromycin, levofloxacin, and sulfamethoxazole-trimethoprim. • Current treatment with immunosuppressive medications as Corticosteroids: Prednisone and Hydrocortisone, Calcineurin Inhibitors as Cyclosporine and Tacrolimus • Current treatment with antipsychotic drugs, antidepressants and mood stabilizers. • Circumstances that interfere with the participant’s ability to give informed consent (diminished understanding or comprehension).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: oReduction in medication use. oChanges in weight, changes in HbA1c, and changes in insulin resistance (HOMA-IR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: o Changes in waist and hip circumference. o Waist-to-hip ratio. o BMI. o Body composition changes | — |
Countries
Egypt
Contacts
Cairo University