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The impact of therapeutic daily intermittent fasting in adult type 2 diabetic patients.

The impact of therapeutic daily intermittent fasting in adult type 2 diabetic patients.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202411524439559
Enrollment
100
Registered
2024-11-18
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

calorie restriction
intermittent Fasting

Sponsors

Cairo university
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Primary Outcomes: oReduction in medication use. oChanges in weight, changes in HbA1c, and changes in insulin resistance (HOMA-IR).

Secondary

MeasureTime frame
Secondary Outcomes: o Changes in waist and hip circumference. o Waist-to-hip ratio. o BMI. o Body composition changes

Countries

Egypt

Contacts

Public ContactMaggie abbassi

Cairo University

maggie.abbassi@pharma.cu.edu.eg01143899732

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026