N/A
N=15
Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02772783 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Nucleus Accumbens Blood Flow — 1.13; 1.16; 1.15; 1.21 ml/g/min per ml/g/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- high GI meal (Other); low GI meal (Other); euglycemic insulin clamp (Drug); primed-variable insulin infusion (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boston Children's Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nucleus Accumbens Blood Flow |
1.12; 1.16; 1.11; 1.20; 1.19; 1.14 | — |
| SECONDARY Nucleus Accumbens Blood Flow |
1.12; 1.16; 1.11; 1.20; 1.19; 1.14 | — |
| SECONDARY Blood Flow in Other Brain Areas Involved in Intake Regulation - Dorsal Caudate |
0.60; 0.59; 0.64 | — |
| SECONDARY Blood Flow in Other Brain Areas Involved in Intake Regulation - Ventrolateral Striatum |
0.60; 0.61; 0.60 | — |
| SECONDARY Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation |
0.36; 0.15; 0.15 | — |
| SECONDARY Functional Connectivity of Nucleus Accumbens, Hypothalamus and Other Brain Areas Involved in Intake Regulation |
0.36; 0.15; 0.15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Insulin resistance (current insulin requirement > 1.5 U/kg/d)
- Insulin requirement 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
Data sourced from ClinicalTrials.gov (NCT02772783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.