Martha Zorn

Insulin Therapy to Improve BMI in Cystic Fibrosis–Related Diabetes Without Fasting Hyperglycemia: Results of the Cystic Fibrosis Related Diabetes Therapy Trial

OBJECTIVE Cystic fibrosis–related diabetes (CFRD) without fasting hyperglycemia (CFRD FH−) is not associated with microvascular or macrovascular complications, leading to controversy about the need for treatment. The Cystic Fibrosis Related Diabetes Therapy (CFRDT) Trial sought to determine whether diabetes therapy improves BMI in these patients. RESEARCH DESIGN AND METHODS A three-arm multicenter randomized trial compared 1 year of therapy with premeal insulin aspart, repaglinide, or oral placebo in subjects with cystic fibrosis who had abnormal glucose tolerance. RESULTS One hundred adult patients were enrolled. Eighty-one completed the study, including 61 with CFRD FH− and 20 with severly impaired glucose tolerance (IGT). During the year before therapy, BMI declined in all groups. Among the group with CFRD FH−, insulin-treated patients lost 0.30 ± 0.21 BMI units the year before therapy. After 1 year of insulin therapy, this pattern reversed, and they gained 0.39 ± 21 BMI units (P = 0.02). No significant change in the rate of BMI decline was seen in placebo-treated patients (P = 0.45). Repaglinide-treated patients had an initial significant BMI gain (0.53 ± 0.19 BMI units, P = 0.01), but this effect was not sustained. After 6 months of therapy they lost weight so that by 12 months there was no difference in the rate of BMI change during the study year compared with the year before (P = 0.33). Among patients with IGT, neither insulin nor repaglinide affected the rate of BMI decline. No significant differences were seen in the rate of lung function decline or the number of hospitalizations in any group. CONCLUSIONS Insulin therapy safely reversed chronic weight loss in patients with CFRD FH−.

Insulin Therapy to Improve BMI in Cystic Fibrosis Related Diabetes Without Fasting Hyperglycemia: Results of the CFRDT Trial

OBJECTIVE Cystic fibrosis–related diabetes (CFRD) without fasting hyperglycemia (CFRD FH−) is not associated with microvascular or macrovascular complications, leading to controversy about the need for treatment. The Cystic Fibrosis Related Diabetes Therapy (CFRDT) Trial sought to determine whether diabetes therapy improves BMI in these patients. RESEARCH DESIGN AND METHODS A three-arm multicenter randomized trial compared 1 year of therapy with premeal insulin aspart, repaglinide, or oral placebo in subjects with cystic fibrosis who had abnormal glucose tolerance. RESULTS One hundred adult patients were enrolled. Eighty-one completed the study, including 61 with CFRD FH− and 20 with severly impaired glucose tolerance (IGT). During the year before therapy, BMI declined in all groups. Among the group with CFRD FH−, insulin-treated patients lost 0.30 ± 0.21 BMI units the year before therapy. After 1 year of insulin therapy, this pattern reversed, and they gained 0.39 ± 21 BMI units (P = 0.02). No significant change in the rate of BMI decline was seen in placebo-treated patients (P = 0.45). Repaglinide-treated patients had an initial significant BMI gain (0.53 ± 0.19 BMI units, P = 0.01), but this effect was not sustained. After 6 months of therapy they lost weight so that by 12 months there was no difference in the rate of BMI change during the study year compared with the year before (P = 0.33). Among patients with IGT, neither insulin nor repaglinide affected the rate of BMI decline. No significant differences were seen in the rate of lung function decline or the number of hospitalizations in any group. CONCLUSIONS Insulin therapy safely reversed chronic weight loss in patients with CFRD FH−.

AIDS education for drug abusers : evaluation of short-term effectiveness

BACKGROUND Interventions are needed to assist drug abusers in reducing risky drug and sexual behavior. METHODS A randomized controlled trial compared three small-group AIDS educational interventions among 567 clients of a 21-day inpatient drug detoxification program: a two-session informational intervention, given either during the first (early) or second (late) week of treatment; and a six-session enhanced intervention. Changes in knowledge, attitudes, and psychomotor skills were assessed before and after each intervention, and behavioral outcomes were assessed at follow-up 10 to 18 weeks after admission. RESULTS Immediately after the interventions, enhanced group members reported significantly greater self-efficacy to talk themselves out of AIDS-risky behavior; other knowledge and attitude scales did not differ by intervention. At follow-up, significant reductions in risky drug use were reported by all groups. Enhanced group members reported significantly greater reduction in injection frequency than did late informational subjects. CONCLUSIONS No beneficial effect was detected of delaying AIDS education for clients entering detoxification. At this early stage of follow-up, there is only weak evidence that an enhanced intervention improved outcomes.

Outcomes of a 21-Day Drug Detoxification Program: Retention, Transfer to Further Treatment, and HIV Risk Reduction

We investigated the outcomes of a 21-day inpatient drug detoxification and rehabilitation program including length of stay, transfer to further treatment, and HIV risky behavior. Clients (n = 567) were predominantly White, male, currently unemployed, and their treatment was not covered by third party payment. 78% were detoxified with methadone. The median length of stay was 18 days. Higher education, not living with spouse or children, English as primary language, admission during fall or winter months, and greater knowledge of HIV transmission were independent predictors of greater length of stay. Among those with follow-up (n = 450), 19% were transferred to residential drug-free programs and 7% to outpatient programs. Taking into account loss to follow-up, the overall rate of treatment transfer could be as low as 21%. Greater length of stay was associated with higher rates of transfer to residential treatment. Relapse rates to either any drug use or injection drug use were lower among subjects transferred to residential treatment than either clients transferred to outpatient programs or those with no further treatment. Among subjects who continued to inject drugs at follow-up, no reduction in HIV risky behaviors was found regardless of further treatment. We conclude that detoxification programs have the potential for reducing relapse to drug use when followed by residential drug-free treatment.

Predictors of AIDS-preventive behavior among homosexually active men: a longitudinal study

Predictors of adoption of safer sexual behaviors were examined in a cohort of 278 homosexually active men with stable HIV-antibody status followed over 12 months at a Boston community health center. The behaviors examined included: (1) restriction of partners to one monogamous or steady relationship and (2) among men who maintained multiple or non-steady partners, the avoidance of unprotected receptive and Insertive anogenital contact. For each behavior, men who adopted consistently safer behavior were compared with those who remained unsafe, using bivariate analyses and multiple logistic regression modelling. The strongest predictor of all behaviors was the initial level of the unsafe behavior. After controlling for this, weak effects of several health beliefs were found, including perceived susceptibility and medical efficacy. Men who became aware of a positive HIV-antibody test result and who reported greater effort to change their behavior were more likely to adopt safer insertive anogenital contact. In this generally well-educated cohort with high levels of knowledge about AIDS, adoption of safer sexual behaviors is best predicted from previous levels of unsafe behavior.

Soil Ingestion Distributions for Monte Carlo Risk Assessment in Children

Monte Carlo environmental risk assessment requires estimates of the exposure distributions. An exposure of principal concern is often soil ingestion among children. We estimate the long-term (annual) average soil ingestion exposure distribution using daily soil ingestion estimates from children who participated in a mass-balance study at Anaconda, MT. The estimated distribution is accompanied by uncertainty estimates. The estimates take advantage of developing knowledge about bias in soil ingestion estimates and are robust. The estimates account for small particle size soil, use the median trace element estimate for subject days, account for the small sample variance of the median estimates, and use best linear unbiased predictors to estimate the cumulative long term soil ingestion distribution. Bootstrapping is used to estimate the uncertainty of the distribution estimates. The median soil ingestion is estimated as 24 mg/d (sd = 4 mg/d), with the 95 percentile soil ingestion estimated as 91 mg/d (sd = 16.6 mg/d). Strategies are discussed for use of these estimates in Monte Carlo risk assessment.

The effectiveness of alternative planned durations of residential drug abuse treatment.

Randomized controlled trials were conducted at two residential drug abuse treatment facilities to compare programs that differed in planned duration. One trial compared a 6-month and a 12-month therapeutic community program (n = 184), and the second compared a 3-month and a 6-month relapse prevention program (n = 444). Retention rates over comparable time periods differed minimally by planned treatment duration, and the longer programs had lower completion rates. There was no effect in either trial of planned treatment duration on changes in psychosocial variables between admission and exit or on rates or patterns of drug use at follow-up between 2 and 6 months after exit.

Planned versus actual duration of drug abuse treatment : Reconciling observational and experimental evidence

The purpose of the study was to evaluate the associations of planned versus actual duration of drug abuse treatment with psychosocial outcomes and drug use at followup. A randomized trial was conducted in a modified therapeutic community in which 444 clients were assigned to programs with planned durations of either 3 or 6 months. Outcomes were psychosocial measures assessing changes in mood and in stage of behavior change between admission and exit and return to drug use and patterns of use 2 to 6 months after exit. Planned duration was not associated with any of the outcomes. A longer actual length of stay was, however, associated with greater improvements in the mood variables; lower rates of drug use at follow-up; and, among those using drugs at follow-up, a longer time from exit to first drug use. Intention-to-treat analyses supported these results. Randomized controlled trials are needed to distinguish the effects of planned duration and actual length of stay.

Elevated depressive symptoms, antidepressant use, and diabetes in a large multiethnic national sample of postmenopausal women

OBJECTIVE To examine elevated depressive symptoms and antidepressant use in relation to diabetes incidence in the Women’s Health Initiative. RESEARCH DESIGN AND METHODS A total of 161,808 postmenopausal women were followed for over an average of 7.6 years. Hazard ratios (HRs) estimating the effects of elevated depressive symptoms and antidepressant use on newly diagnosed incident diabetes were obtained using Cox proportional hazards models adjusted for known diabetes risk factors. RESULTS Multivariable-adjusted HRs indicated an increased risk of incident diabetes with elevated baseline depressive symptoms (HR 1.13 [95% CI 1.07–1.20]) and antidepressant use (1.18 [1.10–1.28]). These associations persisted through year 3 data, in which respective adjusted HRs were 1.23 (1.09–1.39) and 1.31 (1.14–1.50). CONCLUSIONS Postmenopausal women with elevated depressive symptoms who also use antidepressants have a greater risk of developing incident diabetes. In addition, longstanding elevated depressive symptoms and recent antidepressant medication use increase the risk of incident diabetes.

Human immunodeficiency virus type 1 antibody status and changes in risk behavior among drug users

The associations of human immunodeficiency virus type 1 (HIV-1) antibody status and recent testing with risk behavior change were examined in a cohort of drug users enrolled in a randomized trial of acquired immunodeficiency syndrome (AIDS) education programs at a short-term inpatient detoxification facility. Four hundred ninety-seven subjects completed baseline interviews, and 402 (81%) of them had analyzable follow-up information. Changes in eight ordinal self-reported drug and sexual behaviors were assessed using the cumulative logit model for repeated ordinal response data. There was only limited evidence for differential behavior change by either perceived serostatus or recent testing, which was mainly confined to sharing of injection equipment among those who continued to inject, and condom use.