NCT01925248

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

July 31, 2013

Last Update Submit

May 24, 2017

Conditions

Type 2 Diabetes MellitusHyperglycemia

Keywords

Whey proteinprotein supplementDiabetesType 2 DMHyperglycemiaInsulin secretagogue

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose Level

    each day up to 3 months

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Whey protein group

ACTIVE COMPARATOR

Patients will be randomized to receive whey protein

Dietary Supplement: Whey protein

Placebo group

PLACEBO COMPARATOR

Patients will be randomized to receive placebo

Dietary Supplement: Placebo group

Interventions

Whey proteinDIETARY_SUPPLEMENT

Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.

Whey protein group
Placebo groupDIETARY_SUPPLEMENT

Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.

Placebo group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Science Center Clinical Resources Center (CCRC)

Sacramento, California, 95655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperglycemiaDiabetes Mellitus

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sidika E Kasim-Karakas, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 19, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)