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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

Primary Purpose

Type 2 Diabetes Mellitus, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey protein
Placebo group
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical and Translational Science Center Clinical Resources Center (CCRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Whey protein group

Placebo group

Arm Description

Patients will be randomized to receive whey protein

Patients will be randomized to receive placebo

Outcomes

Primary Outcome Measures

Blood Glucose Level

Secondary Outcome Measures

Change in 24 hour urine C-peptide excretion level
Change in Weight
Change in Body Mass Index (BMI)
Change in vital signs
Change in DEXA
Change in Free fatty acids (FFA) levels
Change in Lipid levels
Change in GLP-1 levels
Change in hs-CRP levels
Change in Glycated hemoglobin (HgBA1C) level
Change in Urine glucose level

Full Information

First Posted
July 31, 2013
Last Updated
May 24, 2017
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01925248
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hyperglycemia
Keywords
Whey protein, protein supplement, Diabetes, Type 2 DM, Hyperglycemia, Insulin secretagogue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein group
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive whey protein
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
Primary Outcome Measure Information:
Title
Blood Glucose Level
Time Frame
each day up to 3 months
Secondary Outcome Measure Information:
Title
Change in 24 hour urine C-peptide excretion level
Time Frame
baseline and 1 month up to 3 months
Title
Change in Weight
Time Frame
1 month up to 3 months
Title
Change in Body Mass Index (BMI)
Time Frame
1 month up to 3 months
Title
Change in vital signs
Time Frame
1 month up to 3 months
Title
Change in DEXA
Time Frame
baseline and 1 month up to 3 months
Title
Change in Free fatty acids (FFA) levels
Time Frame
baseline and 1 month up to 3 months
Title
Change in Lipid levels
Time Frame
baseline and 1 month up to 3 months
Title
Change in GLP-1 levels
Time Frame
baseline and 1 month up to 3 months
Title
Change in hs-CRP levels
Time Frame
baseline and 1 month up to 3 months
Title
Change in Glycated hemoglobin (HgBA1C) level
Time Frame
baseline and 1 month up to 3 months
Title
Change in Urine glucose level
Time Frame
baseline and 1 month up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika E Kasim-Karakas, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Center Clinical Resources Center (CCRC)
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

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