Diabetes Mellitus
Conditions
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
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).
Interventions
DRUGInsulin Detemir
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.
DRUGInsulin Glargine
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.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calories Consumed After Fast. | Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks | Total energy ingested following the 24 hour fast. |
Countries
United States
Participant flow
Recruitment details
Sporadic Newspaper advertisement, Albuquerque Journal, July 2008-July 2010.
Pre-assignment details
Three weeks of treatment with each insulin (glargine, detemir) in random order, double blind assignment. Doses of glargine and detemir were equivalent and were based upon existing long acting insulin doses. Doses were titrated up to achieve target fasting glucose \< 150 mg/dl. Both long acting insulins were given once daily before breakfast.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Detemir These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study. | 5 |
| Insulin Glargine These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Insulin Glargine | Insulin Detemir | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 8 | 37 years STANDARD_DEVIATION 14 | 35 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Calories Consumed After Fast.
Total energy ingested following the 24 hour fast.
Time frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Calories Consumed After Fast. | 1418 kcal | Standard Deviation 636 |
| Insulin Glargine | Calories Consumed After Fast. | 1357 kcal | Standard Deviation 576 |