Clinical trial NCT01925248: Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
Official title: Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hyperglycemia
Keywords: Whey protein
protein supplement
Diabetes
Type 2 DM
Hyperglycemia
Insulin secretagogue
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood Glucose Level
timeFrame: each day up to 3 months
Secondary outcomes:
measure: Change in 24 hour urine C-peptide excretion level
timeFrame: baseline and 1 month up to 3 months
measure: Change in Weight
timeFrame: 1 month up to 3 months
measure: Change in Body Mass Index (BMI)
timeFrame: 1 month up to 3 months
measure: Change in vital signs
timeFrame: 1 month up to 3 months
measure: Change in DEXA
timeFrame: baseline and 1 month up to 3 months
measure: Change in Free fatty acids (FFA) levels
timeFrame: baseline and 1 month up to 3 months
measure: Change in Lipid levels
timeFrame: baseline and 1 month up to 3 months
measure: Change in GLP-1 levels
timeFrame: baseline and 1 month up to 3 months
measure: Change in hs-CRP levels
timeFrame: baseline and 1 month up to 3 months
measure: Change in Glycated hemoglobin (HgBA1C) level
timeFrame: baseline and 1 month up to 3 months
measure: Change in Urine glucose level
timeFrame: baseline and 1 month up to 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Clinical and Translational Science Center Clinical Resources Center (CCRC)
state: California
Study officials:
affiliation: University of California, Davis
name: Sidika E Kasim-Karakas, M.D.
role: PRINCIPAL_INVESTIGATOR
References: