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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Detemir | Experimental | Insulin Detemir |
|
| Insulin Glargine | Experimental | Insulin Glargine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Detemir | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Burge, M.D. | University of New Mexico, Department of Internal Medicine, Division of Endocrinology | Principal Investigator |
| Stephen Mitchell, D.O. | University of New Mexico, Department of Internal Medicine, Division of Endocrinology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17881330 | Background | Bush MA. Intensive diabetes therapy and body weight: focus on insulin detemir. Endocrinol Metab Clin North Am. 2007 Aug;36 Suppl 1:33-44. doi: 10.1016/s0889-8529(07)80006-5. | |
| Background | Drugdex System:Klasko RK: Detemir. Drugdex System. Thomson Micromedex, Greenwood Village, Colorado (2007). | ||
| 17391147 |
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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.
Sporadic Newspaper advertisement, Albuquerque Journal, July 2008-July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Insulin Glargine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data for all enrolled subjects in this crossover study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Calories Consumed After Fast. | Total energy ingested following the 24 hour fast. | Posted | Mean | Standard Deviation | kcal | Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Burge | Univ NM | 505-272-4658 | mburge@salud.unm.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Insulin Glargine | Drug | 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. |
|
|
| Background |
| Hermansen K, Davies M. Does insulin detemir have a role in reducing risk of insulin-associated weight gain? Diabetes Obes Metab. 2007 May;9(3):209-17. doi: 10.1111/j.1463-1326.2006.00665.x. |
| 15684339 | Background | Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. doi: 10.1677/joe.1.05866. |
| 16448469 | Background | Tahbaz F, Kreis I, Calvert D. An audit of diabetes control, dietary management and quality of life in adults with type 1 diabetes mellitus, and a comparison with nondiabetic subjects. J Hum Nutr Diet. 2006 Feb;19(1):3-11. doi: 10.1111/j.1365-277X.2006.00668.x. |
| 15047660 | Background | Cruz AF, Calle-Pascual AL; Diabetes and Nutrition Study Group, Spanish Diabetes Association. Diabetes Nutrition and Complications Trial: Trends in nutritional pattern between 1993 and 2000 and targets of diabetes treatment in a sample of Spanish people with diabetes. Diabetes Care. 2004 Apr;27(4):984-7. doi: 10.2337/diacare.27.4.984. No abstract available. |
| 11781763 | Background | Toeller M, Buyken AE, Heitkamp G, Cathelineau G, Ferriss B, Michel G; EURODIAB IDDM Complications Study Group. Nutrient intakes as predictors of body weight in European people with type 1 diabetes. Int J Obes Relat Metab Disord. 2001 Dec;25(12):1815-22. doi: 10.1038/sj.ijo.0801816. |
| 12147141 | Background | Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. doi: 10.1046/j.1464-5491.2002.00790.x. |
| 15356018 | Background | McDuffie JR, Riggs PA, Calis KA, Freedman RJ, Oral EA, DePaoli AM, Yanovski JA. Effects of exogenous leptin on satiety and satiation in patients with lipodystrophy and leptin insufficiency. J Clin Endocrinol Metab. 2004 Sep;89(9):4258-63. doi: 10.1210/jc.2003-031868. |
| 10702749 | Background | Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. |
| 3981480 | Background | Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8. |
| 17381500 | Background | Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. doi: 10.1111/j.1464-5491.2007.02113.x. Epub 2007 Mar 22. |
| 15159223 | Background | de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946. |
| 17082808 | Background | Wynne K, Bloom SR. The role of oxyntomodulin and peptide tyrosine-tyrosine (PYY) in appetite control. Nat Clin Pract Endocrinol Metab. 2006 Nov;2(11):612-20. doi: 10.1038/ncpendmet0318. |
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.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Data for all enrolled subjects. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |