Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Conditions
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Type 2 Diabetes Mellitus, Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey protein group<br>Patients will be randomized to receive whey protein | Dietary Supplement: Whey protein<br>* Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.<br>|
| Placebo Comparator: Placebo group<br>Patients will be randomized to receive placebo | Dietary Supplement: Placebo group<br>* Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level |  | each day up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Lipid 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue