Evaluation of Fats on Postprandial Glucose Control

Type 1 Diabetes Clinical Trial

— Nabucco  

Official title:

Development of "Fat" Bolus for Coverage of Higher Fat Meals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869790
• Other study ID #: Prandial bolus coverage
• Status: Completed
• Phase: N/A
• First received: June 2, 2013
• Last updated: April 25, 2017
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes.

Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals.

The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat.

The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.

Description:

Subjects for this study will be adults with type 1 diabetes who use insulin pump in their diabetes self-management. Prior to admission the the clinical research center the basal rates and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical procedures.

Subjects will be admitted to the clinical research center in mid-morning following a light breakfast at home. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial glucose levels 3-6 hours after start of the meal will be higher following lunches B and D, compared to lunches A and C.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult patients (aged 18-75 years) with type 1 diabetes > 3 years.

• On insulin pump therapy.

• A1c < 8.5%.

Exclusion Criteria:

• History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.

• Eating disorder.

• Diet allergies.

• Special diet restrictions, such as vegan or any nut allergy.

• Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).

• High-titre insulin autoantibodies with delayed insulin kinetics.

• Women who are breast feeding, pregnant, or wanting to become pregnant.

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Other:
• Different fat types
Saturated, monounsaturated fats

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)	One-way repeated measures ANOVA will be used to analyze area under curve differences between the three lunches as well as time in target range (80-180 mg/dL), peak blood glucose, time to peak blood glucose, time to return to baseline blood glucose.	0-180 minutes vs 180-360 minutes