Intermittent Fasting to Improve Insulin Secretion

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Oct 22, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring how a specific eating pattern called intermittent fasting might help improve insulin secretion in people with prediabetes or type 2 diabetes. Insulin is a hormone that helps control blood sugar levels, and improving its secretion could be important for managing or even preventing diabetes. The study will last for four weeks and will look at how this fasting approach affects individuals with different types of glucose metabolism issues.

To participate in this trial, you need to be between 25 and 66 years old, have a body mass index (BMI) between 25 and 40, and either be diagnosed with prediabetes or type 2 diabetes within the last year. You will also need to sign a consent form to confirm your willingness to participate. Throughout the study, you can expect to follow a structured intermittent fasting plan and undergo assessments to see how your insulin secretion changes. It’s important to know that certain health conditions or medications may exclude you from joining the trial, so discussing your specific situation with the study team is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Body mass index (BMI) between 25 - 40 kg/m²
• • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
• • Subjects with prediabetes (IFG and/or IGT, HbA1c 5,4 % - 6,4 %, subphenotype cluster 3 or 5) or
• • Subjects with diabetes mellitus type 2 (diagnosis \< 1 year, HbA1c = 6,5 - 9 %, no medical treatment, subphenotype SIDD or SIRD)
• Exclusion Criteria:
• • Subjects with diabetes mellitus type 1 (GAD-, IA2-AB positive)
• • Women during pregnancy and lactation
• • Treamtent with any medication effecting on glucose metabolism like anti-diabetic drugs or steroids
• • Subjects with a haemoglobin (Hb) ≤ 11.5 g/dl (for males) and Hb ≤ 10.5 g/dl (for females) at screening
• • Any pancreatic disease
• • Medical history of cancer and/or treatment for cancer within the last 5 years.
• • Known current presence or history of severe neurological or psychiatric diseases, schizophrenia, bipolar disorder
• • Known history of bariatric surgery
• • Severe liver or kidney diseases (Alanine Aminotransferase (ALT \[SGPT\]), Aspartate Aminotransferase (AST \[SGOT\]) above 3 x upper limit of normal (ULN) or Glomerular Filtration Rate (eGFR) ≤ 60 ml/min (MDRD formula)
• • Systemic infection (CRP \> 1 mg/dl)
• • Severe diabetic complications like chronic kidney disease (CKD), proliferating retinopathy or symptomatic cardiovascular disease
• • Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
• • Persons with limited temperature sensation and / or elevated sensitivity to warming of the body
• • Persons with a hearing disorder or a increased sensitivity for loud noises
• • Claustrophobia
• • Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study
• • Refusal to get informed of unexpected detected pathological findings