Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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).

Official Title
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Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Detemir
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Detemir<br>Insulin Detemir | Drug: Insulin Detemir<br>* Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.<br>* Other names: Levemir;|
| Experimental: Insulin Glargine<br>Insulin Glargine | Drug: Insulin Glargine<br>* Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calories Consumed After Fast. | Total energy ingested following the 24 hour fast. | Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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