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- Title
Oral Insulin Therapy to Prevent Progression of Immune-Mediated (Type 1) Diabetes.
- Authors
ERGUN‐LONGMIRE, BERRIN; MARKER, JOHN; ZEIDLER, ADINA; RAPAPORT, ROBERT; RASKIN, PHILIP; BODE, BRUCE; SCHATZ, DESMOND; VARGAS, ALFONSO; ROGERS, DOUGLAS; SCHWARTZ, SHERWYN; MALONE, JOHN; KRISCHER, JEFFREY; MACLAREN, NOEL K.
- Abstract
Repeated ingestion of insulin has been suggested as an immune tolerization therapy to prevent immune-mediated (type 1) diabetes. We performed a placebo-controlled, two-dose, oral insulin tolerance trial in newly diagnosed (<2 years) diabetic patients who had required insulin replacement for less than 4 weeks and were found to have cytoplasmic islet cell autoantibodies (ICAs). No oral hypoglycemic agents were permitted during the trial. Endogenous insulin reserves were estimated at six-month intervals by plasma Cpeptide responses to a mixed meal. Positive ICAs were found in 262 (31%) of the 846 patients screened. Of the 197 who agreed to participate, 187 could be followed for 6 to 36 months. Endogenous insulin retention was dependent upon initial stimulated C-peptide response, age at diabetes onset, and numbers of specific islet cell autoantibodies found. Oral insulin improved plasma C-peptide responses in patients diagnosed at ages greater than 20 years, best seen at the low (1 mg/day) over the high (10 mg/day) insulin dose (P = .003 and P = .01, respectively). In patients diagnosed before age 20 years, the 1 mg dose was ineffective, whereas the 10 mg dose actually accelerated C-peptide loss (P = .003). There were no adverse effects. If confirmed, these findings suggest that diabetic patients over age 20 years with ICA evidence of late-onset immune- mediated diabetes should be considered for oral insulin at 1 mg/day to better retain endogenous insulin secretion.
- Subjects
PEOPLE with diabetes; IMMUNOGLOBULINS; DIABETES; CARBOHYDRATE intolerance; PEPTIDES
- Publication
Annals of the New York Academy of Sciences, 2004, Vol 1029, Issue 1, p260
- ISSN
0077-8923
- Publication type
Article
- DOI
10.1196/annals.1309.057