Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of California, Davis
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sidika E. Karakas, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01925248
First received: July 31, 2013
Last updated: August 15, 2013
Last verified: August 2013

July 31, 2013
August 15, 2013
July 2013
June 2015   (final data collection date for primary outcome measure)
Blood Glucose Level [ Time Frame: each day up to 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01925248 on ClinicalTrials.gov Archive Site
  • Change in 24 hour urine C-peptide excretion level [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Weight [ Time Frame: 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Body Mass Index (BMI) [ Time Frame: 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in vital signs [ Time Frame: 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in DEXA [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Free fatty acids (FFA) levels [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Lipid levels [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in GLP-1 levels [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in hs-CRP levels [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Glycated hemoglobin (HgBA1C) level [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
  • Change in Urine glucose level [ Time Frame: baseline and 1 month up to 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hyperglycemia
  • Dietary Supplement: Whey protein
    Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
  • Dietary Supplement: Placebo group
    Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
  • Active Comparator: Whey protein group
    Patients will be randomized to receive whey protein
    Intervention: Dietary Supplement: Whey protein
  • Placebo Comparator: Placebo group
    Patients will be randomized to receive placebo
    Intervention: Dietary Supplement: Placebo group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
25 Years to 70 Years
No
Contact: Sidika E Kasim-Karakas, M.D. (530)752-6254 sekarakas@ucdavis.edu
United States
 
NCT01925248
474531-1
Yes
Sidika E. Karakas, MD, University of California, Davis
University of California, Davis
  • National Institutes of Health (NIH)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Sidika E Kasim-Karakas, M.D. University of California, Davis
University of California, Davis
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP