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
  Purpose

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).


Condition Intervention
Type 2 Diabetes Mellitus
Hyperglycemia
Dietary Supplement: Whey protein
Dietary Supplement: Placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Blood Glucose Level [ Time Frame: each day up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whey protein group
Patients will be randomized to receive whey protein
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.
Placebo Comparator: Placebo group
Patients will be randomized to receive placebo
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.

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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925248

Contacts
Contact: Sidika E Kasim-Karakas, M.D. (530)752-6254 sekarakas@ucdavis.edu

Locations
United States, California
Clinical and Translational Science Center Clinical Resources Center (CCRC) Recruiting
Sacramento, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Sidika E Kasim-Karakas, M.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Sidika E. Karakas, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT01925248     History of Changes
Other Study ID Numbers: 474531-1
Study First Received: July 31, 2013
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Whey protein
protein supplement
Diabetes
Type 2 DM
Hyperglycemia
Insulin secretagogue

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014