Ketogenic diet and type 2 diabetes

Not Applicable

• Conditions: Type 2 diabetes - overweight/obesity; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN28161621
• Lead Sponsor: niversity of Palermo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 22 June 2020
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Group of patients with type 2 diabetes (n=20):
1. Patients of both sexes
2. Age 18 - 65 years
3. BMI 27-39.9 kg/m2
4. DT2 known from <6 years
5. Glycated hemoglobin = 6.5% and <= 10%

Non-diabetic patients (n= 20):
1. Patients of both sexes
2. Age 18 - 65 years
3. BMI 27-39.9 kg/m2
4. Glycated hemoglobin <6.5%; fasting blood glucose <126 mg/dl

Exclusion Criteria

1. Chronic ischemic heart disease (acute coronary syndrome, revascularization procedures)
2. Heart failure class III-IV NYHA
3. Respiratory failure in O2 therapy for COPD, pulmonary fibrosis, bronchial asthma
4. Evidence of renal failure stage =G3a NKF (eGFR- CKD-EPI <60 ml/min/1.73 m2)
5. Liver cirrhosis
6. Type 1 diabetes
7. History of neoplastic disease in the last 10 years
8. Presence of eating behavior disorders
9. Alcohol abuse (>20 g/day for women; >30 g/day for men) and/or drugs
10. Severe psychiatric disorders/use of antipsychotic drugs
11. Insulin therapy
12. Pregnancy or intention of pregnancy
13. Participation in other trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Use of anti-diabetic drugs measured at the end of the study<br> 2. Glycated hemoglobin measured at baseline, 2, 6 and 12 months<br> 3. Carotid IMT/plaques measured using echography at baseline, 2 and 12 months<br> 4. Endothelial function measured using Flow Mediated Dilation (FMD) at baseline, 2 and 12 months<br> 5. Energy expenditure substrates oxidation measured using Indirect Calorimetry at baseline, 2 and 12 months<br> 6. Body composition measured using bioimpedance analysis (BIA) at baseline, 1, 2, 6 and 12 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Fasting plasma glucose, BP, EKG measured at baseline, 1, 2, 6 and 12 months<br> 2. Blood hormonal and chemical data (serum creatinine, hemoglobin, platelets, sodium, potassium, AST, ALT, gamma-GT, continuous non-invasive glucose monitoring, insulin, glucagon, c-peptide and other possible hormonal measurements related to glucose metabolism) measured at baseline, 2 and 12 months<br> 3. Quality of life measured using 36-Item Short Form Health Survey (SF-36) and Impact of Weight on Quality of Life-Lite (IWQOL-Lite) at baseline, 2, 6 and 12 months<br> 4. Inflammation (PCR, cytokines), TC, LDL-C, HDL-c, TG, uric acid at baseline, 2, 6 and 12 months<br> 5. Insulin resistance measured using HOMA/clamp at baseline, 2 and 12 months<br><br>