# Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $639,848

## Abstract

ABSTRACT
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder for women of reproductive age.
Women with PCOS are at a high risk of health complications. In fact, women with PCOS have a 3-7 times
higher risk for type 2 diabetes, and obese women with PCOS have an even higher risk of type 2 diabetes.
Experts recommend that the first-line treatment for overweight and obese women with PCOS should be diet
and lifestyle interventions. Yet, experts disagree about the specific nutritional advice these interventions should
encourage, with different groups recommending no particular diet, a high-carbohydrate Dietary Approaches to
Stop Hypertension (DASH) diet, or a lower carbohydrate diet. A systematic review of previous dietary trials in
PCOS did find a slight benefit of lower carbohydrate diets for glucose control, weight loss, insulin, and insulin
resistance. This may be because carbohydrate intake raises glucose levels, which in turn increases insulin
secretion. Insulin then stimulates ovarian androgen production and inhibits the release of fatty acids from cells.
Previous research in type 2 diabetes suggests that not simply lower carbohydrate intake, but a very low-
carbohydrate (VLC) diet, with less than 20% of calories from carbohydrates, designed to reduce body weight
and glucose levels more significantly than other types of lower carbohydrate diets, would be even more
effective for improving metabolic health in PCOS. Although reviews note that a VLC diet has shown promise
for type 2 diabetes, prediabetes, obesity, and cardiovascular risk, evidence for PCOS is only emerging. In our
recently completed 4-month trial of 29 overweight or obese women with PCOS following a VLC diet, we found
significant improvements in outcomes, including glycated hemoglobin (HbA1c; -0.21%) and body weight
(-7.7%). We propose a 12-month randomized, controlled trial for 184 overweight or obese (BMI of 28-55 kg/m2)
adults with PCOS comparing a VLC diet and a standard-of-care low-fat, Dietary Approaches to Stop
Hypertension (DASH) diet. The program for both groups is delivered online, as in our pilot study. Aim 1: To
compare changes in glycemic control. We hypothesize that the VLC version will lead to greater improvements
in HbA1c at 12-months. Aim 2: To compare changes in secondary health outcomes tied to type 2 diabetes risk,
including glycemic variability, conversion to normoglycemia, body weight, and body fat percentage. We
hypothesize that the VLC version will lead to greater improvements in secondary health outcomes at 12-
months. Aim 3: To explore intervention satisfaction and acceptability. The guiding objective of this proposal is
to explore a novel diet and lifestyle approach for reducing the future risk of type 2 diabetes for overweight or
obese women with PCOS. We anticipate that the proposed research will have an important impact on diet and
lifestyle recommendations for this high-risk, understudied population.

## Key facts

- **NIH application ID:** 10363371
- **Project number:** 1R01DK128205-01A1
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Laura Saslow
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $639,848
- **Award type:** 1
- **Project period:** 2021-12-15 → 2026-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10363371

## Citation

> US National Institutes of Health, RePORTER application 10363371, Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study (1R01DK128205-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10363371. Licensed CC0.

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