High Protein Breakfast on Postprandial Glycemia in T2D (PBD)

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Other: Arm 2 Breakfast- other proteins; Other: Arm 3 Breakfast- low protein

• Registration Number: NCT02854202
• Lead Sponsor: Hospital de Clinicas Caracas

Brief Summary

The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).

Detailed Description

It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Participants: from 30 to 72 years of age
2. BMI: 26 to 34 kg/m2)
3. Diabetes criteria
4. HbA1C: 7-9 % or
5. Habitually eat breakfast
6. Only naïve or treated with metformin.
7. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 3 months
8. Normal liver, kidney and thyroid function.

Exclusion Criteria

1. Type 1 Diabetes
2. Anemia (Hg > 10 g/dL)
3. Serum creatinine level < 1.5 mg/dl
4. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
5. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
6. Infectious disease
7. Pregnant women or lactating
8. Known hypersensitivity to milk components
9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 Breakfast- other proteins	Arm 2 Breakfast- other proteins	In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast
Arm 3 Breakfast- low protein	Arm 3 Breakfast- low protein	In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast

Primary Outcome Measures

Name	Time	Method
Plasma glucose	3 month	Overall postprandial glycemia after breakfast, lunch and dinner

Secondary Outcome Measures

Name	Time	Method
Satiety	3 month	Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.
Change in body weight	3 month	Body weight will be assessed every every two weeks during 3 month