None listed
Conditions
Brief summary
This study aims to determine if metabolic benefits can be attained using free-living Alternate Day Fasting (ADF) as a treatment regime for people with Type 2 Diabetes Mellitus (T2DM). Several case studies have shown that alternate day fasting can improve diabetes status, or eliminate or reduce the need for insulin and hypoglycemic medication. This study will determine if ADF can improve insulin sensitivity and insulin secretion in people with T2DM and to determine if there are changes in non-insulin mediated glucose uptake (NIMGU) and insulin mediated glucose uptake (IMGU). Oxidative stress will also be measured. This is a small-scale, exploratory cohort study to determine if a demonstrable effect will be seen in the New Zealand population. It is hypothesized that ADF will cause short term energy deficit that will cause metabolic changes resulting in increased insulin sensitivity, increased insulin secretion, and reduced blood glucose levels.
Interventions
Each participant will be active in the study for approximately a 2-week period, visiting a study site (University of Canterbury or GP health clinic) a minimum of two times.
Participant interventions include:
- Prior to starting the active 2-week period, the participants will attend a 2-hour information seminar to learn about how fasting will affect insulin requirements, how to manage during fasting periods, and what to eat when not fasting. The seminar will be jointly delivered by the study te
Each participant will be active in the study for approximately a 2-week period, visiting a study site (University of Canterbury or GP health clinic) a minimum of two times. Participant interventions include: - Prior to starting the active 2-week period, the participants will attend a 2-hour information seminar to learn about how fasting will affect insulin requirements, how to manage during fasting periods, and what to eat when not fasting. The seminar will be jointly delivered by the study team including a practicing General Practitioner (GP), a Health Coach with a BAppSc Human Nutrition, and scientific researcher (MSc). The group size will be 10 -12 people in a face-to-face format. Participants will also receive handouts including tips for fasting, do’s and don’ts, planning worksheets, and some recipe ideas. The handouts are designed specifically for this study with some material based, in part, on “The Complete Guide to Fasting” by Jason Fung. - Participants will have a 1-hour personal meeting with the Health Coach to discuss and create a personal plan. - Participants will have 15-minute phone check-ins with the GP or Health Coach on the 6 fasting days to support participation in the trial. - The participants will be asked to observe 6 fasting periods, each lasting up to 24 hours. Fasting periods are scheduled to start on days 2, 4, 6, 8, 10, and 12 with 24 hr periods of normal eating between each fasting period.
Sponsors
Dist. Prof. J. Geoffrey Chase
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Age 18 -70 years Type 2 Diabetes Mellitus Currently use insulin to control blood sugar Ability to give informed consent
Exclusion criteria
Pregnancy Breastfeeding women Medication contraindications Ischemic Heart Disease (IHD) Moderate to severe Chronic Kidney Disease (CKD) Uncontrolled diabetes Currently taking SGLT2 inhibitor Diagnosed eating disorder Malnourishment
Outcome results
None listed