HypoglycemiaNCT05973799
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
A study testing Fasting and Feeding in people with Hypoglycemia and Type1diabetes, run by University of Cincinnati at 1 site in United States.
Trial summary
Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hypoglycemia, Type1diabetes
- What is being tested?
- Fasting and Feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 31 Dec 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- males and females of any race or ethnicity
- non-obese (BMI < or = to 30)
- have a diagnosis of type 1 diabetes
- C-peptide negative
Who cannot join
- pregnant women
- cigarette smoking
- Taking inflammation-targeting steroids (e.g., prednisone).
- Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).
- Hematocrit less than 33%.
- Presence of HIV or hepatitis (due to their deleterious effects on the liver).
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- The presence of cardiovascular or peripheral vascular disease.
- The presence of neuropathy, retinopathy or nephropathy.
- A detection of the presence of any other disease or condition by one of the study doctors, that would be expected to confound the responses to insulin-induced hypoglycemia or make participation in the study dangerous to the individual.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267-0547
Jason Winnick, PhD, 513-558-4437, jason.winnick@uc.edu
About this study
Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T1D will be determined.
Read the detailed description
Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with T1D, thereby reducing hepatic glucose production (HGP) and increasing the depth and duration of the hypoglycemic episode.
The discovery of ways by which counterregulatory responses to hypoglycemia can be improved in people with T1D is a priority. In previous experiments, it was observed that fasting reduces counterregulatory hormone secretion in healthy humans during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (HGP). Therefore, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in people with T1D. It is hypothesized that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia.
Each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. This study design will allow assessment of the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia in a population that is particularly vulnerable to low blood sugar.
- Conditions
- Hypoglycemia, Type1diabetes
- Being tested
- Fasting, Feeding
- Keywords
- glucagon, hepatic glucose metabolism, liver glycogen
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Subjects remain fasted prior to insulin-induced hypoglycemia.
FeedingOther
Subjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Subjects will remain fasted prior to insulin-induced hypoglycemia. Receives: Other: Fasting |
| Feeding | Experimental | Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia. Receives: Other: Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon
From plasma
Measured: During procedure, up to 2.5 hours
Hepatic glucose production
From plasma
Measured: During procedure, up to 2.5 hours
Glucose infusion rate
Amount of glucose required to maintain glycemia at ~55 mg/dL.
Measured: During procedure, up to 2.5 hours
Secondary outcomes (2)
Epinephrine
From plasma
Measured: During procedure, up to 2.5 hours
Peripheral glucose uptake
From plasma
Measured: During procedure, up to 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start10 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject will undergo two metabolic studies, one after having remained fasted and one after having eaten breakfast and lunch.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Winnick, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973799
- Sponsor's protocol ID
- 2019-0816
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05973799
- Acronym / sponsor ID
- 2019-0816
- Conditions
- Hypoglycemia, Type1diabetes
- Keywords
- glucagon, hepatic glucose metabolism, liver glycogen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T1D will be determined.
Detailed description
Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with T1D, thereby reducing hepatic glucose production (HGP) and increasing the depth and duration of the hypoglycemic episode.
The discovery of ways by which counterregulatory responses to hypoglycemia can be improved in people with T1D is a priority. In previous experiments, it was observed that fasting reduces counterregulatory hormone secretion in healthy humans during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (HGP). Therefore, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in people with T1D. It is hypothesized that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia.
Each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. This study design will allow assessment of the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia in a population that is particularly vulnerable to low blood sugar.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject will undergo two metabolic studies, one after having remained fasted and one after having eaten breakfast and lunch.
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: FastingSubjects will remain fasted prior to insulin-induced hypoglycemia. |
| Feeding | Experimental | Other: FeedingSubjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males and females of any race or ethnicity
- non-obese (BMI < or = to 30)
- have a diagnosis of type 1 diabetes
- C-peptide negative
Key exclusion criteria (9 listed)
- pregnant women
- cigarette smoking
- Taking inflammation-targeting steroids (e.g., prednisone).
- Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).
- Hematocrit less than 33%.
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 |
|---|---|---|
| FastingSubjects remain fasted prior to insulin-induced hypoglycemia. | Other | Fasting |
| FeedingSubjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia. | Other | Feeding |
Primary outcome
Glucagon
Time frame: During procedure, up to 2.5 hours
From plasma
Hepatic glucose production
Time frame: During procedure, up to 2.5 hours
From plasma
Glucose infusion rate
Time frame: During procedure, up to 2.5 hours
Amount of glucose required to maintain glycemia at ~55 mg/dL.
2 secondary outcomes
Epinephrine
Time frame: During procedure, up to 2.5 hours
Peripheral glucose uptake
Time frame: During procedure, up to 2.5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Feeding in people with Hypoglycemia and Type1diabetes, run by University of Cincinnati 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Winnick, PhD (513-558-4437, jason.winnick@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon (time frame: During procedure, up to 2.5 hours). The study lists 3 primary outcomes in all. 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 3 Sep 2024.