Type 2 Diabetes MellitusNCT01925248
Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
A study testing Whey protein in people with Type 2 Diabetes Mellitus and Hyperglycemia, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hyperglycemia
- What is being tested?
- Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2016
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with type 2 DM; age: 25 to 70y; BMI: 25 - 40 kg/m2; on no drug treatment or on metformin alone; HgBA1 6.5 - 8.5%; urinary microalbumin < 30 mg/g cr.
Who cannot join
- Systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: > 5% weight change, smoking, alcohol intake > 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . Pregnant women, prisoners, individuals who cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Center Clinical Resources Center (CCRC)
Sacramento, California, 95655
About this study
The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).
Read the detailed description
11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.
Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.
Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia
- Being tested
- Whey protein, Placebo group
- Keywords
- Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
Placebo groupDietary supplement
Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein group | Active comparator | Patients will be randomized to receive whey protein Receives: Dietary Supplement: Whey protein |
| Placebo group | Placebo comparator | Patients will be randomized to receive placebo Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
Measured: each day up to 3 months
Secondary outcomes (11)
Change in 24 hour urine C-peptide excretion level
Measured: baseline and 1 month up to 3 months
Change in Weight
Measured: 1 month up to 3 months
Change in Body Mass Index (BMI)
Measured: 1 month up to 3 months
Change in vital signs
Measured: 1 month up to 3 months
Change in DEXA
Measured: baseline and 1 month up to 3 months
Change in Free fatty acids (FFA) levels
Measured: baseline and 1 month up to 3 months
Change in Lipid levels
Measured: baseline and 1 month up to 3 months
Change in GLP-1 levels
Measured: baseline and 1 month up to 3 months
Change in hs-CRP levels
Measured: baseline and 1 month up to 3 months
Change in Glycated hemoglobin (HgBA1C) level
Measured: baseline and 1 month up to 3 months
Change in Urine glucose level
Measured: baseline and 1 month up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Sidika E Kasim-Karakas, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925248
- Sponsor's protocol ID
- 474534
- Other IDs
- A-13-001-UCD-SK-NH
- Status last verified
- May 2017
- First submitted
- 31 Jul 2013
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
- ClinicalTrials.gov ID
- NCT01925248
- Acronym / sponsor ID
- 474534
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia
- Keywords
- Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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.
The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).
Detailed description
11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.
Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.
Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein group | Active comparator | Dietary Supplement: Whey proteinPatients will be randomized to receive whey protein |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupPatients will be randomized to receive placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women with type 2 DM; age: 25 to 70y; BMI: 25 - 40 kg/m2; on no drug treatment or on metformin alone; HgBA1 6.5 - 8.5%; urinary microalbumin < 30 mg/g cr.
Key exclusion criteria (1 listed)
- Systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: > 5% weight change, smoking, alcohol intake > 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . Pregnant women, prisoners, individuals who cannot provide informed consent.
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 |
|---|---|---|
| Whey proteinWhey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months. | Dietary supplement | Whey protein group |
| Placebo groupPlacebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months. | Dietary supplement | Placebo group |
Primary outcome
Blood Glucose Level
Time frame: each day up to 3 months
11 secondary outcomes
Change in 24 hour urine C-peptide excretion level
Time frame: baseline and 1 month up to 3 months
Change in Weight
Time frame: 1 month up to 3 months
Change in Body Mass Index (BMI)
Time frame: 1 month up to 3 months
Change in vital signs
Time frame: 1 month up to 3 months
Change in DEXA
Time frame: baseline and 1 month up to 3 months
Change in Free fatty acids (FFA) levels
Time frame: baseline and 1 month up to 3 months
Change in Lipid levels
Time frame: baseline and 1 month up to 3 months
Change in GLP-1 levels
Time frame: baseline and 1 month up to 3 months
Change in hs-CRP levels
Time frame: baseline and 1 month up to 3 months
Change in Glycated hemoglobin (HgBA1C) level
Time frame: baseline and 1 month up to 3 months
Change in Urine glucose level
Time frame: baseline and 1 month up to 3 months
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 30 May 2017.
- 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.
Sidika E Kasim-Karakas, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein in people with Type 2 Diabetes Mellitus and Hyperglycemia, run by University of California, Davis 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 1 inclusion and 1 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 30 May 2017. 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. Some participants in this study may receive a placebo. 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?
Blood Glucose Level (time frame: each day up to 3 months). 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 30 May 2017.