Carbohydrate modified diet & insulin sensitizers reduce body weight & modulate metabolic syndrome measures in EMPOWIR (enhance the metabolic profile of women with insulin resistance)

A randomized trial of normoglycemic women with midlife weight gain

Harriette R. Mogul, Ruth Freeman, Khoa Nguyen, Michael Frey, Lee Ann Klein, Sheila Jozak, Karen Tanenbaum

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Rationale: Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women. Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion. Objective: To assess a previously reported novel hypocaloric carbohydrate modified diet alone (D), and in combination with metformin (M) and metformin plus low-dose rosiglitazone (MR), in diverse women with midlife weight gain (defined as > 20lbs since the twenties), normal glucose tolerance, and hyperinsulinemia. Participants: 46 women, mean age 46.6±1.0, BMI 30.5±0.04 kg/m2, 54.5% white, 22.7% black, 15.9% Hispanic, at 2 university medical centers. Methods: A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization. Main Outcome Measure: Change in 6-month fasting insulin. Pre-specified secondary outcomes were changes in body weight, HOMA-IR, metabolic syndrome (MS) measures, leptin, and adiponectin. Results: Six-month fasting insulin declined significantly in the M group: 12.5 to 8.0 μU/ml, p = .026. Mean 6-month weight decreased significantly and comparably in D, M, and MR groups: 4.7, 5.4, and 5.5% (p's.049, .002, and.032). HOMA-IR decreased in M and MR groups (2.5 to 1.6 and 1.9 to 1.3, p's = .054, .013). Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups. Notably, mean fasting leptin did not decline in a subset of subjects with weight loss (26.15±2.01 ng/ml to 25.99±2.61 ng/ml, p = .907. Adiponectin increased significantly in the MR group (11.1±1.0 to 18.5±7.4, p<.001) Study medications were well tolerated. Conclusions: These findings suggest that EMPOWIR's easily implemented dietary interventions, alone and in combination with pharmacotherapies that target hyperinsulinemia, merit additional investigation in larger, long-term studies. Trial Registration: ClinicalTrials.gov NCT00618072

Original languageEnglish (US)
Article numbere108264
JournalPLoS One
Volume9
Issue number9
DOIs
StatePublished - Sep 26 2014

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Metabolome
metabolic syndrome
Nutrition
insulin resistance
metformin
Weight Gain
fasting
Insulin Resistance
adiponectin
insulin
hyperinsulinemia
weight gain
Body Weight
Carbohydrates
Insulin
Diet
carbohydrates
leptin
Fasting
body weight

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Carbohydrate modified diet & insulin sensitizers reduce body weight & modulate metabolic syndrome measures in EMPOWIR (enhance the metabolic profile of women with insulin resistance) : A randomized trial of normoglycemic women with midlife weight gain. / Mogul, Harriette R.; Freeman, Ruth; Nguyen, Khoa; Frey, Michael; Klein, Lee Ann; Jozak, Sheila; Tanenbaum, Karen.

In: PLoS One, Vol. 9, No. 9, e108264, 26.09.2014.

Research output: Contribution to journalArticle

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abstract = "Rationale: Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women. Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion. Objective: To assess a previously reported novel hypocaloric carbohydrate modified diet alone (D), and in combination with metformin (M) and metformin plus low-dose rosiglitazone (MR), in diverse women with midlife weight gain (defined as > 20lbs since the twenties), normal glucose tolerance, and hyperinsulinemia. Participants: 46 women, mean age 46.6±1.0, BMI 30.5±0.04 kg/m2, 54.5{\%} white, 22.7{\%} black, 15.9{\%} Hispanic, at 2 university medical centers. Methods: A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization. Main Outcome Measure: Change in 6-month fasting insulin. Pre-specified secondary outcomes were changes in body weight, HOMA-IR, metabolic syndrome (MS) measures, leptin, and adiponectin. Results: Six-month fasting insulin declined significantly in the M group: 12.5 to 8.0 μU/ml, p = .026. Mean 6-month weight decreased significantly and comparably in D, M, and MR groups: 4.7, 5.4, and 5.5{\%} (p's.049, .002, and.032). HOMA-IR decreased in M and MR groups (2.5 to 1.6 and 1.9 to 1.3, p's = .054, .013). Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups. Notably, mean fasting leptin did not decline in a subset of subjects with weight loss (26.15±2.01 ng/ml to 25.99±2.61 ng/ml, p = .907. Adiponectin increased significantly in the MR group (11.1±1.0 to 18.5±7.4, p<.001) Study medications were well tolerated. Conclusions: These findings suggest that EMPOWIR's easily implemented dietary interventions, alone and in combination with pharmacotherapies that target hyperinsulinemia, merit additional investigation in larger, long-term studies. Trial Registration: ClinicalTrials.gov NCT00618072",
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