Clinical trial NCT00659165: Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
Official title: Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
insulin dependent diabetes
diabetes mellitus
detemir
levemir
glargine
lantus
insulin
appetite
satiety
centrally acting mediators of satiety
three factor eating questionnaire
PYY
ghrelin
leptin
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn \[NPH\], glargine) except that it has been associated with less weight gain compared to other types of insulin. The reasons for this are still unclear. One possibility is that detemir insulin acts differently than do other insulins in affecting how diabetic patients eat meals. The purpose of this study is to determine whether appetite and calories eaten during a meal are affected by the type of insulin used to treat diabetes. This is a pilot study which means we are gathering preliminary information to determine if a larger study can be done.

Detailed description: Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain that may allow for improved central nervous system activity and effects on satiety. The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine. Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY \[PYY\], ghrelin, leptin).

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Treated with long-acting and meal time insulin therapy for at least 2 years
* Ages 18 to 60 years of age
* Glycosylated hemoglobin value between 7 - 9 mg/dL
* C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.

Exclusion Criteria:

* Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
* Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
* Pregnancy
* Alcohol or drug abuse or dependence within three months of study entry
* Less than 50 % agreement on 50-item Food Questionnaire with the Food Array "buffet style" study meal.
* Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.

Primary outcomes:
measure: Calories Consumed After Fast.
timeFrame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
affiliation: University of New Mexico, Department of Internal Medicine, Division of Endocrinology
name: Mark Burge, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico, Department of Internal Medicine, Division of Endocrinology
name: Stephen Mitchell, D.O.
role: STUDY_DIRECTOR
References:
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