Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
- Conditions
- HyperglycemiaType 2 Diabetes Mellitus
- Interventions
- Dietary Supplement: Whey proteinDietary Supplement: Placebo group
- Registration Number
- NCT01925248
- Lead Sponsor
- University of California, Davis
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whey protein group Whey protein Patients will be randomized to receive whey protein Placebo group Placebo group Patients will be randomized to receive placebo
- Primary Outcome Measures
Name Time Method Blood Glucose Level each day up to 3 months
- Secondary Outcome Measures
Name Time Method Change in 24 hour urine C-peptide excretion level baseline and 1 month up to 3 months Change in Weight 1 month up to 3 months Change in Body Mass Index (BMI) 1 month up to 3 months Change in vital signs 1 month up to 3 months Change in DEXA baseline and 1 month up to 3 months Change in Free fatty acids (FFA) levels baseline and 1 month up to 3 months Change in GLP-1 levels baseline and 1 month up to 3 months Change in hs-CRP levels baseline and 1 month up to 3 months Change in Glycated hemoglobin (HgBA1C) level baseline and 1 month up to 3 months Change in Urine glucose level baseline and 1 month up to 3 months Change in Lipid levels baseline and 1 month up to 3 months
Trial Locations
- Locations (1)
Clinical and Translational Science Center Clinical Resources Center (CCRC)
🇺🇸Sacramento, California, United States