Ketogenic diet and type 2 diabetes

Ketogenic Diet and Action in Diabetes: evaluation of safety, efficacy and possible mechanisms of action. A 12-month, single-centre, randomized, open, intervention study comparing ketogenic diet versus conventional diet in obese subjects with and without type 2 diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28161621

Enrollment

Registered

2018-11-23

Start date

2019-01-15

Completion date

Unknown

Last updated

2020-06-22

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

Conditions

Type 2 diabetes - overweight/obesity Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Participants are asked to join this study while they are at the outpatient clinic for obesity and T2D. Participants are randomly allocated using a computer-generated list of random numbers to one of t

women: ideal body weight x 1,2) and lipids. Phase 2 (40 days): 2 portions of vegetables and 1 portion of protein foods (meat, fish, eggs, cured meats) will be added. Ph

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. Fasting plasma glucose, BP, EKG measured at baseline, 1, 2, 6 and 12 months 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 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 4. Inflammation (PCR, cytokines), TC, LDL-C, HDL-c, TG, uric acid at baseline, 2, 6 and 12 months 5. Insulin resistance measured using HOMA/clamp at baseline, 2 and 12 months	—

Measure

Time frame

1. Fasting plasma glucose, BP, EKG measured at baseline, 1, 2, 6 and 12 months 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 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 4. Inflammation (PCR, cytokines), TC, LDL-C, HDL-c, TG, uric acid at baseline, 2, 6 and 12 months 5. Insulin resistance measured using HOMA/clamp at baseline, 2 and 12 months

—

Countries

Italy

Contacts

Public ContactSilvio Buscemi

silvio.buscemi@unipa.it+39 (0)91 6552250

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026