The University of Michigan PCOS Intervention Using Nutritional Ketosis

University of Michigan

Status and phase

Completed

Phase 2

Phase 1

Conditions

Polycystic Ovary Syndrome

Treatments

Behavioral: diet and lifestyle program

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03987854

K01DK107456 (U.S. NIH Grant/Contract)

HUM00113697

P30DK092926 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

Full description

Polycystic ovary syndrome (PCOS) is a common and costly ($4.3 billion/year) endocrine disorder that significantly impairs quality of life and increases the risk of obesity and type 2 diabetes as well as hyperandrogenism, infertility, hyperlipidemia, and cardiovascular disease. Diet and lifestyle weight-loss interventions are recommended as the first-line treatment of PCOS, but experts disagree about which nutritional approach is best. A review of previous diet and lifestyle trials in PCOS did find a slight benefit of lower carbohydrate diets for weight loss, glucose control, insulin, and insulin resistance. This may be because carbohydrate intake leads to increased insulin secretion, which then stimulates ovarian androgen production and inhibits the release of fatty acids from cells, both of which worsen PCOS-related issues. Although lower carbohydrate diets may be helpful, research from other populations with or at risk of type 2 diabetes suggests that prior PCOS studies may have set insufficient carbohydrate reduction targets. The investigators propose that a very-low carbohydrate diet may be needed to especially benefit women with PCOS, as greater carbohydrate reduction should have a larger impact on androgen levels and weight loss. Thus, the goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

Enrollment

29 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

We will include women in one PCOS subtype, those having these two symptoms:
- Hyperandrogenism - (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism
- oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year.

Participants must also be:

overweight or obese (BMI 25-50)
be 21-40 years old
have regular access to the internet
be able to engage in light physical activity
willing and able to follow the assigned intervention.

Exclusion criteria

a non-English speaker
inability to complete baseline measurements
a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy)
pregnant or planning to get pregnant in the next 6 months
type 1 or type 2 diabetes
baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal
baseline renal disease defined as BUN > 30 mg/dL or serum creatinine >1.4 mg/dL
baseline uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML)
breastfeeding or less than 6 months post-partum
planned or history of weight loss surgery
vegan or vegetarian
currently enrolled in a weight loss program or other investigative study that might conflict with this research
taking medications known to cause weight gain or loss
taking hypoglycemic medications other than metformin or medications known to affect metabolism
or patients with other etiologies of anovulation and hyperandrogenism, e.g., Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of congenital adrenal hyperplasia, organic intra cranial lesion such as a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens.