Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Diabetes Mellitus, Type 1
Interventions
OTHER

high GI meal

High and low GI liquid test meals are matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals will provide 25% of individual daily energy requirements as estimated by the Harris Benedict equation. A high glycemic index of \~90 is achieved by using corn syrup as a carbohydrate source.

OTHER

low GI meal

High and low GI liquid test meals are matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals will provide 25% of individual daily energy requirements as estimated by the Harris Benedict equation. A low glycemic index of \~40 is achieved by using uncooked corn starch as a carbohydrate source.

DRUG

euglycemic insulin clamp

Insulin will be given intravenously for 5 hours. During the entire clamp protocol, glucose levels will be measured every 5 minutes. A basal insulin infusion will be started at 80% of the patients insulin pump basal rate, and will be adjusted between 0.1 and 2.5 mU/kg•min, depending upon the patient's plasma glucose level in relation to the target range target of 90-100 mg/dl.

DRUG

primed-variable insulin infusion

A primed-variable infusion of insulin will be administered at the rate established to achieve euglycemia after a low glycemic index meal. This is expected to result in moderate hyperglycemia as the high GI meal is associated with higher insulin requirements. For patient safety, glucose levels will be measured every 30 minutes. If glucose levels are \> 400 mg/dl or \< 60 mg/dl, insulin infusion will be adjusted to maintain glucose levels target of 60-400 mg/dl.

Trial Locations (1)

02115

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Brigham and Women's Hospital

OTHER

lead

Boston Children's Hospital

OTHER

NCT02772783 - Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter