Diabetes MellitusNCT04416204
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
A study testing glycogen loading and No Glycogen Loading in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- glycogen loading and No Glycogen Loading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 15 Feb 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-75
- BMI 20-35kg/m^2
- Participants with type 2 diabetes:
- HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)
Who cannot join
- Pregnancy or breast feeding
- Morbidities precluding participation
- Participants with type 2 diabetes:
- Therapy with insulin
- SGLT2 inhibitors
- GLP-1 based approaches
Show all 15Show fewer
- TZDs
- Unstable diabetic retinopathy
- Microalbuminuria
- Macrovascular disease
- Medications affecting GI motility (eg., erythromycin, pramlintide)
- Upper GI disorder/surgery
- Participants without diabetes:
- Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
- History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Role of Hepatic Glycogen on Nocturnal EGP in T2D
The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.
Read the detailed description
Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2
- Being tested
- glycogen loading, No Glycogen Loading
- Keywords
- Diabetes Mellitus, hepatic glycogen, endogenous glucose production
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycogen loadingOther
Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
No Glycogen LoadingOther
Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Experimental | Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. Receives: Other: glycogen loading; Other: No Glycogen Loading |
| Participants without diabetes | Experimental | Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. Receives: Other: glycogen loading; Other: No Glycogen Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.
Measured: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Secondary outcomes (2)
Rates of Glycogenolysis in Subjects With Type 2 Diabetes
Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.
Measured: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Rates of Gluconeogenesis in Healthy Subjects
Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.
Measured: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Aug 2020
- Primary completion15 Aug 2022
- Study completion15 Feb 2023
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Basu, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416204
- Sponsor's protocol ID
- 22074
- Other IDs
- R01DK029953
- Status last verified
- Feb 2024
- First submitted
- 1 Jun 2020
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hepatic Glycogen on Nocturnal EGP in T2D
- ClinicalTrials.gov ID
- NCT04416204
- Acronym / sponsor ID
- 22074
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, hepatic glycogen, endogenous glucose production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.
Detailed description
Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | Experimental | Other: glycogen loading, Other: No Glycogen LoadingParticipants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. |
| Participants without diabetes | Experimental | Other: glycogen loading, Other: No Glycogen LoadingParticipants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-75
- BMI 20-35kg/m^2
- Participants with type 2 diabetes:
Key exclusion criteria (15 listed)
- Pregnancy or breast feeding
- Morbidities precluding participation
- Participants with type 2 diabetes:
- Participants without diabetes:
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 |
|---|---|---|
| glycogen loadingSubjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. | Other | Participants without diabetes, Type 2 diabetes |
| No Glycogen LoadingSubjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. | Other | Participants without diabetes, Type 2 diabetes |
Primary outcome
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
Time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.
2 secondary outcomes
Rates of Glycogenolysis in Subjects With Type 2 Diabetes
Time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Rates of Gluconeogenesis in Healthy Subjects
Time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycogen loading and No Glycogen Loading in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham 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 15 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 1 Mar 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?
Yes. Results are posted in the registry (first posted 18 Dec 2023). 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?
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes (time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 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 1 Mar 2024.