DiabetesNCT01792986
The Fasting II Study
A study testing water-only 24-hour fasting once per week for 6 weeks in people with Diabetes and Metabolic Diseases, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Diabetes, Metabolic Diseases
- What is being tested?
- water-only 24-hour fasting once per week for 6 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female, ≥30 and <70 years of age.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Prior evidence of pre-diabetic state, with one of the following:
- Pre-diabetic with a measured hemoglobin A1c (HbA1c) ≥6.0% or fasting glucose >100 mg/dL without a clinical diabetes diagnosis
- Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
- Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
Show all 11Show fewer
- Fasting glucose level >100 mg/dL.
- Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
- High-density lipoprotein cholesterol <40 mg/dL in males or <50 mg/dL in females.
- Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
- Waist circumference >40 inches (102 cm) for males or >35 inches (88 cm) for females (or body mass index >25 kg/m2).
Who cannot join
- Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
- Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
- Very low body mass index (BMI) (<18.5 kg/m2) or high BMI (>40 kg/m2).
- Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
- Any immunodeficiency or prior solid organ transplantation or renal disease.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Medical Center
Murray, Utah, 84107
Intermountain Medical Center
Salt Lake City, Utah, 84107
About this study
Official title: Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial
This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).
- Conditions
- Diabetes, Metabolic Diseases
- Being tested
- water-only 24-hour fasting once per week for 6 weeks
- Keywords
- Diabetes, Fasting, Pre-diabetes, Hemoglobin A1C
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Fasting, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-only 24-hour fasting once per week for 6 weeksBehavioural
| Study group | Role | What they receive |
|---|---|---|
| water-only 24-hour fasting once per week for 6 weeks | Other | Not described Receives: Behavioral: water-only 24-hour fasting once per week for 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
Measured: 6 weeks
Secondary outcomes (4)
Difference in Weight Between Baseline and the End of the Sixth Week
Measured: 6 weeks
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.
Measured: 6 weeks
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.
Measured: 6 weeks
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Benjamin D Horne, PhD, MPH, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792986
- Sponsor's protocol ID
- 1024469
- Status last verified
- Jul 2013
- First submitted
- 12 Feb 2013
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial
- ClinicalTrials.gov ID
- NCT01792986
- Acronym / sponsor ID
- 1024469
- Conditions
- Diabetes, Metabolic Diseases
- Keywords
- Diabetes, Fasting, Pre-diabetes, Hemoglobin A1C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 3 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| water-only 24-hour fasting once per week for 6 weeks | Other | Behavioral: water-only 24-hour fasting once per week for 6 weeks |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or non-pregnant female, ≥30 and <70 years of age.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Prior evidence of pre-diabetic state, with one of the following:
- Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
Key exclusion criteria (8 listed)
- Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
- Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
- Very low body mass index (BMI) (<18.5 kg/m2) or high BMI (>40 kg/m2).
- Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
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 |
|---|---|---|
| water-only 24-hour fasting once per week for 6 weeks | Behavioural | water-only 24-hour fasting once per week for 6 weeks |
Primary outcome
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
Time frame: 6 weeks
4 secondary outcomes
Difference in Weight Between Baseline and the End of the Sixth Week
Time frame: 6 weeks
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.
Time frame: 6 weeks
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.
Time frame: 6 weeks
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
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.
Benjamin D Horne, PhD, MPH principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water-only 24-hour fasting once per week for 6 weeks in people with Diabetes and Metabolic Diseases, run by Intermountain Health Care, Inc. at 2 sites 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2017.