Evaluation of Fats on Postprandial Glucose Control

NCT01869790 | Completed DMC

• 1 other identifier: Prandial bolus coverage
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Meal challenge

EXPERIMENTAL

Different fat types

Other: Different fat types

Interventions

Different fat types OTHER

Saturated, monounsaturated fats

Meal challenge

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18-75 years) with type 1 diabetes \> 3 years.
• On insulin pump therapy.
• A1c \< 8.5%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Howard Wolpert, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)