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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Hyperglycemia
Type 2 Diabetes Mellitus

Treatments

Dietary Supplement: Whey protein
Dietary Supplement: Placebo group

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01925248
474534
A-13-001-UCD-SK-NH (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

32 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 2 patient groups, including a placebo group

Whey protein group
Active Comparator group
Description:
Patients will be randomized to receive whey protein
Treatment:
Dietary Supplement: Whey protein
Placebo group
Placebo Comparator group
Description:
Patients will be randomized to receive placebo
Treatment:
Dietary Supplement: Placebo group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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