Diabetes Type 2NCT03938441
Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
A study testing Intermittent Fasting in people with Diabetes Type 2 and Pre-diabetes, run by gino gaddini at 1 site in United States.
Trial summary
The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes Type 2, Pre-diabetes
- What is being tested?
- Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Active Duty members and DoD beneficiaries ages 18-69
- Diagnosed with Type 2 Diabetes or pre-diabetic
- Prescribed/taking Metformin 500mg to 2000mg daily
Who cannot join
- History of recurrent hypoglycemic events on present medication regimen
- Drugs/medication with known increase in hypoglycemic events [Include basal insulin, rapid acting insulin, sulfonylureas, etc.). Metformin is not known to cause hypoglycemia.
- Pregnant
- Medication-induced or secondary diabetes
- Known abnormal hematocrit
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).
Read the detailed description
This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting.
In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
- Conditions
- Diabetes Type 2, Pre-diabetes
- Being tested
- Intermittent Fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
The version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Modified 5:2 intermittent fasting Receives: Other: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic events
This study's intent is to investigate the safety of this intervention for use in a broader scope. It is imperative that risks are known for each subpopulation of diabetics. To this point, our literature review indicates that hypoglycemic events did occur at higher rates in fasting populations taking hypoglycemic medications. We intend to look at rates of hypoglycemia on those not on hypoglycemic medications to assess if this trend continues.
Measured: Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start31 Jul 2019
- Primary completion28 May 2021
- Study completion28 May 2021
Why it stopped: Slow enrollment and PI Graduating Residency in June 2021.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- gino gaddini
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, gino gaddini, Mike O'Callaghan Military Hospital
- Investigators
- Paul F Crawford, MD, Study director, US Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938441
- Sponsor's protocol ID
- FWH20190059H
- Status last verified
- Jun 2021
- First submitted
- 1 May 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data
Publications
Carter S, Clifton PM, Keogh JB. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial. Diabetes Res Clin Pract. 2016 Dec;122:106-112. doi: 10.1016/j.diabres.2016.10.010. Epub 2016 Oct 19.
PubMed 27833048Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.
PubMed 28465792Azevedo FR, Ikeoka D, Caramelli B. Effects of intermittent fasting on metabolism in men. Rev Assoc Med Bras (1992). 2013 Mar-Apr;59(2):167-73. doi: 10.1016/j.ramb.2012.09.003.
PubMed 23582559Ash S, Reeves MM, Yeo S, Morrison G, Carey D, Capra S. Effect of intensive dietetic interventions on weight and glycaemic control in overweight men with Type II diabetes: a randomised trial. Int J Obes Relat Metab Disord. 2003 Jul;27(7):797-802. doi: 10.1038/sj.ijo.0802295.
PubMed 12821964Horne BD, Muhlestein JB, Anderson JL. Health effects of intermittent fasting: hormesis or harm? A systematic review. Am J Clin Nutr. 2015 Aug;102(2):464-70. doi: 10.3945/ajcn.115.109553. Epub 2015 Jul 1.
PubMed 26135345Corley BT, Carroll RW, Hall RM, Weatherall M, Parry-Strong A, Krebs JD. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial. Diabet Med. 2018 May;35(5):588-594. doi: 10.1111/dme.13595. Epub 2018 Feb 27.
PubMed 29405359Genuth S, Eastman R, Kahn R, Klein R, Lachin J, Lebovitz H, Nathan D, Vinicor F; American Diabetes Association. Implications of the United kingdom prospective diabetes study. Diabetes Care. 2003 Jan;26 Suppl 1:S28-32. doi: 10.2337/diacare.26.2007.s28. No abstract available.
PubMed 12502617Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2015.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
- ClinicalTrials.gov ID
- NCT03938441
- Acronym / sponsor ID
- FWH20190059H
- Conditions
- Diabetes Type 2, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and PI Graduating Residency in June 2021.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- gino gaddiniUS federal agency
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).
Detailed description
This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting.
In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Other: Intermittent FastingModified 5:2 intermittent fasting |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female Active Duty members and DoD beneficiaries ages 18-69
- Diagnosed with Type 2 Diabetes or pre-diabetic
- Prescribed/taking Metformin 500mg to 2000mg daily
Key exclusion criteria (5 listed)
- History of recurrent hypoglycemic events on present medication regimen
- Drugs/medication with known increase in hypoglycemic events [Include basal insulin, rapid acting insulin, sulfonylureas, etc.). Metformin is not known to cause hypoglycemia.
- Pregnant
- Medication-induced or secondary diabetes
- Known abnormal hematocrit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingThe version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies. On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories. Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day. | Other | Intermittent Fasting |
Primary outcome
Number of hypoglycemic events
Time frame: Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks
This study's intent is to investigate the safety of this intervention for use in a broader scope. It is imperative that risks are known for each subpopulation of diabetics. To this point, our literature review indicates that hypoglycemic events did occur at higher rates in fasting populations taking hypoglycemic medications. We intend to look at rates of hypoglycemia on those not on hypoglycemic medications to assess if this trend continues.
Results and safety
The study was stopped early (reason given: Slow enrollment and PI Graduating Residency in June 2021.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 27833048Carter S, Clifton PM, Keogh JB. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial. Diabetes Res Clin Pract. 2016 Dec;122:106-112. doi: 10.1016/j.diabres.2016.10.010. Epub 2016 Oct 19.
- Background: PubMed 28465792Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.
- Background: PubMed 23582559Azevedo FR, Ikeoka D, Caramelli B. Effects of intermittent fasting on metabolism in men. Rev Assoc Med Bras (1992). 2013 Mar-Apr;59(2):167-73. doi: 10.1016/j.ramb.2012.09.003.
- Background: PubMed 12821964Ash S, Reeves MM, Yeo S, Morrison G, Carey D, Capra S. Effect of intensive dietetic interventions on weight and glycaemic control in overweight men with Type II diabetes: a randomised trial. Int J Obes Relat Metab Disord. 2003 Jul;27(7):797-802. doi: 10.1038/sj.ijo.0802295.
- Background: PubMed 26135345Horne BD, Muhlestein JB, Anderson JL. Health effects of intermittent fasting: hormesis or harm? A systematic review. Am J Clin Nutr. 2015 Aug;102(2):464-70. doi: 10.3945/ajcn.115.109553. Epub 2015 Jul 1.
- Background: PubMed 29405359Corley BT, Carroll RW, Hall RM, Weatherall M, Parry-Strong A, Krebs JD. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial. Diabet Med. 2018 May;35(5):588-594. doi: 10.1111/dme.13595. Epub 2018 Feb 27.
- Background: PubMed 12502617Genuth S, Eastman R, Kahn R, Klein R, Lachin J, Lebovitz H, Nathan D, Vinicor F; American Diabetes Association. Implications of the United kingdom prospective diabetes study. Diabetes Care. 2003 Jan;26 Suppl 1:S28-32. doi: 10.2337/diacare.26.2007.s28. No abstract available.
- BackgroundCenters for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2015.
- Individual participant dataSharing planned: No. We do not plan on sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Crawford, MD study director
US Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Diabetes Type 2 and Pre-diabetes, run by gino gaddini at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment and PI Graduating Residency in June 2021.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoglycemic events (time frame: Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938441, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.