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Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03727854
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital

Brief Summary:
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.

Condition or disease Intervention/treatment Phase
Patients With Type 2 Diabetes Dietary Supplement: Premeal protein enriched bar Behavioral: Dietary modification Not Applicable

Detailed Description:
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group1
Premeal protein enriched bar with dietary modification
Dietary Supplement: Premeal protein enriched bar
Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).

Behavioral: Dietary modification
Subjects in this group will follow diabetes diet education.

Group2
Dietary modification only
Behavioral: Dietary modification
Subjects in this group will follow diabetes diet education.




Primary Outcome Measures :
  1. Change in HbA1c from baseline [ Time Frame: 0 week, 12 weeks ]

Secondary Outcome Measures :
  1. Change in fasting blood glucose level from baseline [ Time Frame: 0 week, 12 weeks ]
  2. Change in body weight from baseline [ Time Frame: 0 week, 12 weeks ]
  3. Change in waist circumference from baseline [ Time Frame: 0 week, 12 weeks ]
  4. Change in blood Triglyceride level from baseline [ Time Frame: 0 week, 12 weeks ]
  5. Change in blood High-density lipoprotein level from baseline [ Time Frame: 0 week, 12 weeks ]
  6. Change in blood Low-density lipoprotein level from baseline [ Time Frame: 0 week, 12 weeks ]
  7. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline [ Time Frame: 0 week, 12 weeks ]
  8. Change in Homeostatic Model Assessment of β-cell function (HOMA-beta) from baseline [ Time Frame: 0 week, 12 weeks ]


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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 18.5~35 kg/m2
  • Type 2 diabetes patients
  • Fasting blood glucose ≥ 126 mg/dl or
  • HbA1c ≥ 6.5% or
  • Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.

Exclusion Criteria:

  • HbA1c < 6.5% or > 10%
  • Subjects using insulin other than basal insulin
  • Subjects who have newly started or have changed anti diabetic drugs within 3 months
  • Subjects who are allergic to grains, nuts, legumes and milk
  • Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
  • Subjects with chronic unstable disease
  • Subjects with cognitive impairments who are not able to follow the study protocol
  • Females who are pregnant or doing breast feeding
  • Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
  • Subjects with hemoglobin level of less than 10.0 g/dL
  • Subjects with alcohol addiction or drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727854


Contacts
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Contact: Sun Joon Moon, MD 82-2-2072-2228 ipleat.m@gmail.com
Contact: Young Min Cho, MD, PhD 82-2-2072-1965 ymchomd@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Young Min Cho, MD, PHD    82-2-2072-1965    ymchomd@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital

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Responsible Party: Young Min Cho, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03727854     History of Changes
Other Study ID Numbers: H-1804-120-940
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Young Min Cho, Seoul National University Hospital:
protein-enriched bar
glycemic control
type 2 diabetes
long term
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases