Type 2 DiabetesHPDNCT05615558
High-Protein Diets and Diabetes
A study testing Dietary Intervention in people with Type 2 Diabetes, run by University of Exeter at 1 site in United Kingdom.
Trial summary
High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2022to 1 Jul 2023
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-70 y
- Body-mass index of 27-45 kg/m2
- Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only).
- Males and females
Who cannot join
- Habitual dietary intake of <0.6 or >1.2 g/kg/day protein (determined from dietary history interview given at screening)
- Current use of insulin
- HbA1c of 12% or more (≥108 mmol/mol)
- Weight loss of more than 5 kg within the past 6 months
- A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min,
- Heart failure,
- Participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nutritional Physiology Research Unit
Exeter, Devon, EX12LU
About this study
Official title: The Impact of a High-Protein Diet From Animal vs. Non-Animal Sources on Insulin Sensitivity and β-cell Function in Type 2 Diabetes
High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. They also improve glucose control and so may be helpful for treatment of Type 2 Diabetes (T2D), particularly in the short-term, possibly via an improvement in insulin secretion. Indeed, HP diets may be uniquely effective at promoting insulin secretion in T2D, but further research is needed to understand why HP. Thus, there is an urgent need to determine how HP diets affect T2D pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. It is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable HP diet that can improve glucose control and T2D pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- Dietary Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Controlled dietary intervention; all food is provided to participants after being allocated to animal or non-animal dietary protein, for a duration of 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Animal | Experimental | Arm of the study consuming a high-protein diet from animal sources. Receives: Other: Dietary Intervention |
| Non-animal | Experimental | Arm of the study consuming a high-protein diet from non-animal sources. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity.
Measured: Change from Baseline insulin sensitivity after 5-week controlled diet
Secondary outcomes (4)
β-cell function
β-cell function measured by modelling of glucose, insulin and c-peptide during MMTT
Measured: Change from Baseline β-cell function after 5-week controlled diet
Glucose control
Glucose control measured by fasting glucose, 2 hour MMTT glucose, 24-hour glucose profile using continuous glucose monitoring probe and HbA1c.
Measured: Change from Baseline glucose control after 5-week controlled diet
Branched-chain amino acid (BCAA) metabolism
BCAA metabolism measured by plasma BCAA concentration.
Measured: Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet
Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire
Treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ).
Measured: Change from Baseline treatment satisfaction after 5-week controlled diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Marlow Foods Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615558
- Sponsor's protocol ID
- 275134
- Acronym
- HPD
- Status last verified
- Jan 2025
- First submitted
- 26 May 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a High-Protein Diet From Animal vs. Non-Animal Sources on Insulin Sensitivity and β-cell Function in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05615558
- Acronym / sponsor ID
- HPD / 275134
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Marlow Foods Ltd
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 14 Nov 2022 (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.
High-protein (HP) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. They also improve glucose control and so may be helpful for treatment of Type 2 Diabetes (T2D), particularly in the short-term, possibly via an improvement in insulin secretion. Indeed, HP diets may be uniquely effective at promoting insulin secretion in T2D, but further research is needed to understand why HP. Thus, there is an urgent need to determine how HP diets affect T2D pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. It is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable HP diet that can improve glucose control and T2D pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of T2D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal | Experimental | Other: Dietary InterventionArm of the study consuming a high-protein diet from animal sources. |
| Non-animal | Experimental | Other: Dietary InterventionArm of the study consuming a high-protein diet from non-animal sources. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 40-70 y
- Body-mass index of 27-45 kg/m2
- Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only).
- Males and females
Key exclusion criteria (7 listed)
- Habitual dietary intake of <0.6 or >1.2 g/kg/day protein (determined from dietary history interview given at screening)
- Current use of insulin
- HbA1c of 12% or more (≥108 mmol/mol)
- Weight loss of more than 5 kg within the past 6 months
- A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min,
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 |
|---|---|---|
| Dietary InterventionControlled dietary intervention; all food is provided to participants after being allocated to animal or non-animal dietary protein, for a duration of 5 weeks. | Other | Animal, Non-animal |
Primary outcome
Insulin sensitivity
Time frame: Change from Baseline insulin sensitivity after 5-week controlled diet
Rate of disappearance (Rd) during the hyperinsulinaemic-euglycaemic clamp from participants on each diet, a measure of insulin sensitivity.
4 secondary outcomes
β-cell function
Time frame: Change from Baseline β-cell function after 5-week controlled diet
Glucose control
Time frame: Change from Baseline glucose control after 5-week controlled diet
Branched-chain amino acid (BCAA) metabolism
Time frame: Change from Baseline BCAA after 1, 2, 3, 4 and 5 weeks of controlled diet
Diabetes treatment satisfaction measured by the diabetes treatment satisfaction questionnaire
Time frame: Change from Baseline treatment satisfaction after 5-week controlled diet
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 17 Jan 2025.
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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 Dietary Intervention in people with Type 2 Diabetes, run by University of Exeter at 1 site in United Kingdom.
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 7 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 17 Jan 2025. 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 Kingdom. 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?
Insulin sensitivity (time frame: Change from Baseline insulin sensitivity after 5-week controlled diet). 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 17 Jan 2025.