HealthyPROLOGNCT04283318
Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
A study testing 12h fasting and 36h fasting in people with Healthy and Obesity, run by Medical University of Graz at 1 site in Austria.
Trial summary
In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- 12h fasting and 36h fasting
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jun 2018to 28 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Gender: Both, male and female Minimum Age: 18 years
Inclusion Criteria Cohort I (Healthy, non-obese subjects) Age >18 years; body mass index in the range of 20.0-27.0 kg/m2; fasting plasma glucose <110mg/dL
Inclusion criteria cohort II (Obese subjects) Age >18 years; body mass index >30 kg/m2; fasting plasma glucose <110mg/dL
Inclusion Criteria Cohort III (Cohort with subjects with Type 2 Diabetes Mellitus) Age >18 years; established Diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, Dipeptidylpeptidase (DPP)-4-inhibitors or sulfonylurea
Inclusion Criteria Cohort IV (Cohort with subjects with Type 1 Diabetes Mellitus) Age >18 years; diagnosed with Type 1 Diabetes Mellitus >12 months; treated with multiple daily Insulin injectioins (MDII) or continuous subcutaneous Insulin Infusion (CSII); stable Insulin therapy as clinically assessed by the study physician; C-Peptide negative defined as 0.3 nmol/L; HbA1c <9.5%; no diabetic ketoacidosis within the last 12 months; no severe hypoglycaemia requiring external assistance within the last 12 months; running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring
Exclusion Criteria (for all participants) History of cardiovascular disease; acute or chronic inflammatory disorder; heavy drinking (more than 15 drinks/week); dietary restrictions (e.g. vegetarianism and vegan); insulin Treatment (excluded subjects with Type 1 Diabetes Mellitus); corticosteroid therapy; known malignancy; women who are pregnant, breast-feeding or trying to become pregnant; history of any chronic disease process that could interfere with interpretation of study results; therapy with antidepressants within past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects.
The aim of this research project is to investigate the effect of short and midterm fasting (12 hours versus 36 hours) on glucose metabolism, glucose regulatory hormones, insulin secretion and resting energy expenditure in healthy and obese people as well as in patients with type 2 diabetes.
Read the detailed description
In this clinical study, we want to examine the effects of different fasting periods (12 hours versus 36 hours) on blood sugar levels and other metabolic parameters and hormones. For this the following investigations are carried out:
- Oral glucose tolerance test with detailed laboratory evaluation
- Bio-impedance measurement to determine body composition (muscle and fat mass)
The examinations are carried out on 4 different cohorts (normal healthy persons, obese patients, patients with type 2 diabetes and patients with type 1 diabetes).
- Conditions
- Healthy, Obesity, Type 2 Diabetes Mellitus, Type 1 Diabetes
- Being tested
- 12h fasting, 36h fasting
- Keywords
- starvation, healthy people, obese, Type 2 diabetes mellitus, glucose metabolism, Type 1 diabetes mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12h fastingBehavioural
12h fasting (overnight)
36h fastingBehavioural
36h fasting ( one day and two nights fasting)
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Other | Age >18 years; BMI 20-27 kg/m2; Fasting plasma Glucose <110 mg/dL Receives: Behavioral: 12h fasting; Behavioral: 36h fasting |
| Obese people | Other | Age >18 years; BMI >30 kg/m2; Fasting Plasma Glucose <110 mg/dL Receives: Behavioral: 12h fasting; Behavioral: 36h fasting |
| Type 2 Diabetes | Other | Age >18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea) Receives: Behavioral: 12h fasting; Behavioral: 36h fasting |
| Type 1 Diabetes | Other | Age >18 years; Diagnosed Type 1 Diabetes mellitus >12 months; Treated with multiple daily Insulin injections (MDII) or continuous subcutaneous Insulin Infusion (CSII); Stable Insulin therapy as clinically assessed by the study physician C-Peptide negative defined as 0.3 nmol/L; No diabetic ketoacidosis within the last 12 months; No severe hypoglycaemia requiring external assistance within the last 12 months; Running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring Receives: Behavioral: 12h fasting; Behavioral: 36h fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 2h glucose levels
Difference in the change of 2h glucose levels in an oral glucose tolerance test
Measured: after 12 and 36 hours of fasting
Secondary outcomes (6)
changes in insulin sensitivity (QUICKI)
differences in QUICKI
Measured: after 12 and 36 hours of fasting
changes in insulin sensitivity (Matsuda Index)
differences in Matsuda Index
Measured: after 12 and 36 hours of fasting
changes in insulin sensitivity (ISI)
differences in ISI
Measured: after 12 and 36 hours of fasting
changes in insulin sensitivity (HOMA-Index)
differences in HOMA-Index
Measured: after 12 and 36 hours of fasting
Changes in glycaemic pattern
differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test
Measured: after 12 and 36 hours of fasting
Changes in body composition
differences in bioimpedance analysis
Measured: after 12 and 36 hours of fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start13 Jun 2018
- Primary completion26 Feb 2020
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Sourij, MD, Principal investigator, Medical University of Graz, Auenbruggerplatz 15
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283318
- Sponsor's protocol ID
- HS-2018-01
- Acronym
- PROLOG
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04283318
- Acronym / sponsor ID
- PROLOG / HS-2018-01
- Conditions
- Healthy, Obesity, Type 2 Diabetes Mellitus, Type 1 Diabetes
- Keywords
- starvation, healthy people, obese, Type 2 diabetes mellitus, glucose metabolism, Type 1 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Feb 2020 (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.
In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects.
The aim of this research project is to investigate the effect of short and midterm fasting (12 hours versus 36 hours) on glucose metabolism, glucose regulatory hormones, insulin secretion and resting energy expenditure in healthy and obese people as well as in patients with type 2 diabetes.
Detailed description
In this clinical study, we want to examine the effects of different fasting periods (12 hours versus 36 hours) on blood sugar levels and other metabolic parameters and hormones. For this the following investigations are carried out:
- Oral glucose tolerance test with detailed laboratory evaluation
- Bio-impedance measurement to determine body composition (muscle and fat mass)
The examinations are carried out on 4 different cohorts (normal healthy persons, obese patients, patients with type 2 diabetes and patients with type 1 diabetes).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | Other | Behavioral: 12h fasting, Behavioral: 36h fastingAge >18 years; BMI 20-27 kg/m2; Fasting plasma Glucose <110 mg/dL |
| Obese people | Other | Behavioral: 12h fasting, Behavioral: 36h fastingAge >18 years; BMI >30 kg/m2; Fasting Plasma Glucose <110 mg/dL |
| Type 2 Diabetes | Other | Behavioral: 12h fasting, Behavioral: 36h fastingAge >18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea) |
| Type 1 Diabetes | Other | Behavioral: 12h fasting, Behavioral: 36h fastingAge >18 years; Diagnosed Type 1 Diabetes mellitus >12 months; Treated with multiple daily Insulin injections (MDII) or continuous subcutaneous Insulin Infusion (CSII); Stable Insulin therapy as clinically assessed by the study physician C-Peptide negative defined as 0.3 nmol/L; No diabetic ketoacidosis within the last 12 months; No severe hypoglycaemia requiring external assistance within the last 12 months; Running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 12h fasting12h fasting (overnight) | Behavioural | Healthy, Obese people, Type 1 Diabetes, Type 2 Diabetes |
| 36h fasting36h fasting ( one day and two nights fasting) | Behavioural | Healthy, Obese people, Type 1 Diabetes, Type 2 Diabetes |
Primary outcome
change of 2h glucose levels
Time frame: after 12 and 36 hours of fasting
Difference in the change of 2h glucose levels in an oral glucose tolerance test
6 secondary outcomes
changes in insulin sensitivity (QUICKI)
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (Matsuda Index)
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (ISI)
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (HOMA-Index)
Time frame: after 12 and 36 hours of fasting
Changes in glycaemic pattern
Time frame: after 12 and 36 hours of fasting
Changes in body composition
Time frame: after 12 and 36 hours of fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Harald Sourij, MD principal investigator
Medical University of Graz, Auenbruggerplatz 15
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12h fasting and 36h fasting in people with Healthy and Obesity, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Mar 2022. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of 2h glucose levels (time frame: after 12 and 36 hours of fasting). 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 2 Mar 2022.