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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

Processed carbohydrates cause rapid changes in blood sugar and have been associated with overeating and obesity. We have shown that test meals high in processed carbohydrate affect brain areas involved in addiction, craving and overeating. It is unknown whether the changes in blood sugar or the associated higher insulin levels mediate this brain activation and its likely adverse effects. Answering this question is important for patients with type 1 diabetes who have elevated risks of obesity and disordered eating: If blood sugar is the causal mechanism, optimal insulin coverage should be protective. If insulin is the causal mechanism, however, a diet high in processed carbohydrate could predispose to overeating and weight gain, as this diet requires higher insulin doses. To disentangle these factors, we will study brain activation and relevant blood markers in 15 men with diabetes. In 4 sessions, we will examine meals with differential carbohydrate properties while giving insulin infusions.

Key facts

Study ID

NCT02772783

Run by

Boston Children's Hospital

People needed

15

Starts

2016-07-01

Expected to finish

2018-05-01

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes for a minimum of 3 years
• BMI 20-35 kg/m2
• Use of insulin pump
• Willing and able to: Maintain weight and document for duration of the study

You may not qualify if…

• Insulin resistance (current insulin requirement > 1.5 U/kg/d)
• Insulin requirement < 0.5 unit/kg/day (cut-off for preserved beta-cell function)
• HbA1C ≥ 8.0%
• DKA within 2 months
• Frequent hypoglycemia (BG <50 mg/dl), > 3 times per week
• Fluctuations in body weight >10% over preceding year
• Smoking or illicit substance abuse
• High levels of physical activity (≥60 minutes per day, ≥ 4 days per week)
• Current weight loss diet
• Medical problems, medications or dietary supplements that may affect metabolism, insulin action, body weight, appetite, energy expenditure, or gastrointestinal absorption (e.g. celiac disease)
• Allergies to compounds or intolerance of the liquid meals
• MRI exclusion criteria
• Other conditions according to self-report that would prohibit participation based and researcher assessment

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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